דרושים Quality Control Technician Ii ב-טבע ב-הודו

• Ensures that the Product Quality Reviews / Annual Product Reviews for Teva products are completed in a timely and compliant manner as per Teva’s CORP Quality Management systems. PQR/APR compilation and approval must be well associated with the Teva Manufacturing Sites, Global Quality Units and Commercial affiliates to meet the targets and ensure compliance.
• Ensures timely and accurate data migration in collaboration with sites and Global IT / IT Quality
• Ensures timely review of CMC documentation in collaboration with Global R&D sites
• Defines team operating standards and ensures essential CORP and local procedures are followed based on knowledge of own discipline.
• Manages and supervises a team of up to 100 professional employees consisting of sr. managers, managers, authors reviewers and approvers.
• Is accountable for the performance and results of a teams within the function Global Quality GBS.
• Creates and adapts departmental plans and priorities to address resource and operational challenges.
• Ensures that decisions are guided by CORP policies, procedures and Global Quality´s business plan.
• Receives guidance from Senior Director Quality Strategy and Shared Services, SVP Global Quality, other Managers in Quality Strategy and Shared Services, Global R&D, Global IT, EMSO Quality affiliates, Commercial Quality EU & IM, TGO sites.

A.Review and approval of PQR’s

The owner of the function

• Review of Annual Product Reviews (APRs) / Product Quality Reviews (PQRs) for products supplied by external vendors and manufactured at external manufactures
• Conduct review of (APRs) / Product Quality Reviews (PQRs) prepared by team members to ensure high quality of the reports prepared by the team.
• Recommend actions and communicate to stakeholder for identified actions as part of the review process to improve quality of products(CAPA)
• Approve Annual Product Reviews (APRs) / Product Quality Reviews (PQRs) which do not require approval step by any other TEVA /non-TEVA stakeholder like QPs, RPs or FvPs.
• Support and guide in escalation of PQR issues and initiate and conduct meetings / telecons if required on priority.

B.Data Migration

• Ensure Data Migration is performed in accordance with TEVA requirements in the pre-given timeline and accuracy
• Support and guide in escalation of DM issues and initiate and conduct meetings / telecons if required on priority.
• Escalate the issues of the DM team to higher management for non-responsive TEVA’s internal stake holders, missing resources, missing commitments etc.

C.R&D CMC Documentation
• Ensure review of CMC documents received from R&Ds is performed in accordance with TEVA requirements in the pre-given timeline and accuracy
• Support and guide in escalation of issues and initiate and conduct meetings / telecons if required on priority.
• Escalate the issues to higher management for non-responsive TEVA’s internal stake holders, missing resources, missing commitments etc.

D.Quality Management Systems

The owner of the function

• Ensures that the local quality management system is maintained at GBS Quality function.
• Ensures that the local Quality Management System is compliant with respective regulatory guidelines and TEVA´s CORP QMS (Gap Assessments)
• Approves process of change controls and deviations
• Approves local SOP’s and its related documents.

E.Performance Management

• Monitors and compiles the KPI scores of the various business units and supports the team to improve their efficiency.
• Participates in the customers council meetings and supports the effectiveness of the councils.
• Leads or participates in the Monthly Quality Council and enhances the effectiveness and efficiency of it by suitable reports/metrices and continuous improvement.

The incumbent

• Approves Training Materials for GMP training and on the job training.
• Imparts training on procedures as needed.
• Reviews the training status of the team and regularly verifies that training was performed in time and successfully.
• Certifies trainers and self-inspectors to enable them to impart training and conduct self-inspection.

G.Miscellaneous Support

The owner of the function is responsible for

• Hiring of new Headcount and monitoring the Head count status
• Maintaining Employee Central and other relevant Master Data
• Liase with Finance related to the HC cost
• Responsible for approval of PR’s related to purchase of PQR’s.
• Review the invoicing cost involved with respect to the status.
• Approval of POs in SAP- for hiring and other requests like purchase orders for costs involved in updation of software
• Review monthly report to be presented to higher management

• More than 15 years of experience in QA / QC function in the pharmaceutical industry
• More than 5 years of experience in a managerial role
• Well-founded knowledge on worldwide cGxP regulations
• Excellent English language skills, other language skills could be helpful
• Very Good communication skills and ability to work in a matrix structure
• Very good knowledge of Computerised Systems in TEVA´s IT landscape (Track-Wise, SAP, LIMS, Global Insights, Glorya etc.)
• Good understanding of manufacturing, QC and Contract manufacturing processes
• Engagement to drive improvements and ability to manage complexity
• Mobility

VP Global Quality SMSO

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

• To perform Stability analysis.
• Maintenance of operating instruments / equipment.
• To maintain the assigned Laboratory workplace, instruments and equipment etc.
• To adhere Good Laboratory Practices (GLP), Good Documentation Practices (GDP), relevant regulatory guidelines and PAL procedure.
• Responsible for handling , operating and maintaining HPLC / UV and related instruments to ensure optimal performance.
• Adherence to Good Laboratory Practices (GLP), Good Documentation Practices (GDP), relevant regulatory guidelines and PAL procedure.
• Performing stability testing (Assay, RS & Dissolution) of all formulations by HPLC and UV techniques.
• Preparing samples and executing the same as per the Method of Analysis and Verification of sample set sequence in applicable software’s.
• Interpreting chromatographic data and ensuring proper documentation of all analytical activities in compliance with GLP / GDP requirements
• Reporting of interpreted data in line with specification, compliance and regulatory standards and maintaining data integrity throughout the analytical lifecycle.
• Evaluation of reported results and reporting of any abnormal results to the supervisor ontime.
• Handling of laboratory software's.
• Ensure to use safety apparels and PPEs while working in the laboratory.
• Ensure timely completion of assigned training.

• M.Sc., Chemistry
• 7+ years of experience

• Operation and maintenance of HVAC & Compressed air system & Nitrogen plant. Also responsible for filter cleaning, whole plant AC’s monitoring & maintenance, cooling systems, small projects, improvement, new initiatives, energy saving, modification, automation, new process developments. Etc. of site.
• Perform the preventive maintenance and filter cleaning activity as per the schedule.
• Co-ordination with cross functional departments.
• Preventive maintenance and filter cleaning schedule preparation for all HVAC, Dust collector, Dehumidifire system.
• Keep maintain all log books and building maintenace record.
• Perform the validation of HVAC systems as per the scheduler with the co-ordination with external vendor
• Adher the calibration planner for the all instruments in service floor and other utilities.
• Check and adhere all legal, health and safety regulations are being followed inline to Teva standards.
• Maintain the HVAC system inline to the Quality and Safety standards of Teva.
• Upkeep the Equipment availability by analysing and reducing the breakdowns and performing the Scheduled maintenance activities.
• Leads work area in his shifts and ensures personal safety and also make ensures the whole execution activity would be performed as per site safety compliance and procedures.
• Monitor and take care the contractor safety and induction, also routine evaluation of safe practices.
• Work in ERP, and other QMS software’s.
• Keep the facility in good condition (5S) with proper building maintenance.
• Responsible to work in shift all the Shifts.
• Execute activities & deliverables, and prepare required reports as per the direction of manager.
• Execute GEP documentation like qualification, validation, change management, Project management and other quality-related engineering documentation.
• Also has to take care the operation and maintenance of Remaining utilities like Chillers, hot water pumps, cooling towers, Boilers, Water systems, ETP, Fire pump house, Electrical systems, safety compliance activities, Building maintenance of non-manufacturing area.
• To work as per cGMP guideline and upkeep the HVAC facility and all time readiness for audit.
• Identifying the critical spares, consumables for the service floor area and keep them in stock.
• Executing of periodical servicing, annual maintenance and other Engineering related works
• Supervise contractors/vendor/OEMs and non-payroll manpower. Also, clarify their tasks and required resources.
• To perform any other job assigned by reporting supervisor and Engineering HOD.

• ITI / Diploma
• 7+ years

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

• Detailed description of MAIN tasks and responsibilities:
• Performing Stability analysis, Method transfer, Method Validation and review of analytical documents.
• Preparation and review of Method Transfer Protocols (MTP), Method transfer report (MTR), Method of analysis (MTH), Standard Testing Procedure, Test Data Sheet (TDS) for Stability Analysis, Method transfer and Method Validation, Stability Summary Reports and any document related to stability analysis, method transfer and method validation in compliance with current guidelines. Review and maintenance of all logbooks of the department
• Preparation of departmental SOP’s in compliance with current guidelines. Review of departmental SOP’s, training of analysts and other technical staff and review validation of data transfer, data management using computer systems.
• Preparation and review of validation protocols in compliance with current guidelines.
• Calibration and validation of all instruments / equipments.
• Entry of stability sample results in LIMS & SAP.
• Handling of LSCMS software
• Initiation of Quality Forms in Track wise Harmony, documents in Glorya EDMS and CAPA in Trackwise Harmony.

• M. Pharmacy
• 10 years and 7 months of experience

• Monthly review of Health Canada brand safety updates.
• Align updates with internal product lists and communicate relevant changes to cross-functional teams.
• Strategize and implement changes impacting multiple product documents.
• Track and retrieve the latest innovator PMs from the Health Canada Drug Product Database.
• Create and update Teva PMs by referencing Canadian innovator products.
• Use tools like TVT for document comparison, ensuring compliance with HC master templates.
• Perform thorough QC, editing, formatting, and coordinating the review and approval processes.
• Collaborate with French translators for bilingual PMs.
• Coordinate with artwork team the creation of packaging components (Inserts/Outserts/Cartons/Labels) for sANDS submissions.
• Manage the Veeva Artwork Process to obtain final artworks.
• Conduct quality reviews of labeling and submission documents using manual proofreading and electronic tools (TVT).
• Support other safety Level III updates and regulatory commitments in collaboration with the Canada RA team.
• Address Health Canada queries including clarifaxes, screening acceptance, pause-the-clock requests, extensions, BA/BE queries, and withdrawals.
• Maintain accurate project trackers to monitor due dates, priorities, and timelines for all assigned projects.
• Keep databases updated and share current PMs and relevant details with internal and external stakeholders.
• Collaborate with the RA Canada team on safety-related submissions such as Advisement Letters and Level III changes.
• Ensure timely eCTD-compliant submissions in coordination with Regulatory Operations and publishing software.
• Stay current with Health Canada regulations, guidelines, and SOPs.
• Work effectively in a team environment with minimal supervision.
• Perform additional job-related duties as required by management and evolving processes.

• Pharma Graduate / Post Graduate with a Scientific or Regulatory background or equivalent combination of education and experience
• 3+ years of experience in Regulatory Affairs with a focus on Canadian labeling.
• Knowledge of Health Canada regulatory requirements related to Canadian labeling
• Knowledge of XML/SPM development and Health Canada requirements.

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

The role of the RIM team is to:

• Develop and implement the RA business systems strategy required to ensure that Global Regulatory Affairs (GRA) systems continue to meet ongoing and emerging business needs.
• Provide the expert business analysis input required for the successful development of strategic system roadmaps and for the successful implementation of the projects required to ensure the delivery of the technology solutions required to support the GRA business and its partner functions.
• Provide RA Business Data Administration and Business System Ownership, including system and data related business change management, in support of the RA business process and data requirements, and compliant system usage.
• Partner with external pharmaceutical industry stakeholders (e.g. industry associations) and health authorities to influence outcomes relating to emerging requirements such as ISO IDMP and FMD etc.
• Manage and deliver the Teva XEVMPD submissions related to Investigational Medicinal Products, review and remediate Authorized Medicinal Products 3rd acknowledgment and EMA follow up reports to ensure Article 57 compliance.
• Support PV in case of audits and inspections, provide Teva XEVMPD records EV web reports, review and/or remediate the Teva xevmpd records (if required) including collaboration on CAPA plan in case any finding is related to RIM/xevmpd data
• Support the in-house Regulatory Data Administration team for the management of Teva registration data. This includes support for data integration and data integrity/enrichment initiatives to ensure compliant and reliable RA data for accurate reporting and business decisions making.

TheRIM Business Analyst/Project Managerwill support and enable the successful execution of this role.

• Responsible for supporting effective business project management for regional and global projects focused on improving regulatory data quality, the provisioning of regulatory data for internal re-use via system integration, or the implementation of any business or technology change that impacts regulatory data and documents or the regulatory technology landscape.
• Required to lead cross-regional and cross-functional projects teams, working and influencing staff at all levels within the organization to ensure regulatory systems, and related processes, are developed and enhanced to meet the diverse regulatory business process and data requirements.

The
RIM Business Analyst/Project Managerwill work closely with the Harlow based RIM and GRO Regulatory Data Administration teams. Will work closely with the GRA functional teams dependent upon these operations. Will act as change manager, and/or escalation point for these operations to ensure their continued effectiveness, and to ensure GRA business needs continue to be met by these operations.

• They will be an effective Business Analyst, responsible for deep dives in to current and mapping future business process, be expert in interrogating regulatory legislative and guidance documents and draw on that expertise to shape the to-be processes to ensure business compliance.
• Responsible for providing effective Business Data Administration oversight for GRA data (e.g. for the data management/data quality decisions that impact system dictionary-controlled values and for defining, obtaining agreement to, and communicating, GRA data process related work instructions etc.)
• Must be fluent with Pharmaceutical Regulatory Affairs business processes.
• Must leverage deep regulatory business expertise to successfully partner with Regulatory Affairs functional/strategy teams, and IT etc.
• Must understand evolving regulatory requirements and guidelines.
• Must be able to understand and define new RA business requirements, translate those into strategic project proposals for change and to deliver those projects.
• Must be analytical, methodical, and able to successfully analyse data, process, and external regulatory requirements.
• Must be a highly effective communicator, capable of relaying complex concepts to all levels and functions of the company.

Qualfication:

• Required: Bachelor’s Degree in Life Sciences or Information Technology
• Preferred: MS in scientific or information technology discipline

Required:

• 3 to 5 demonstrable experiences of the pharmaceutical industry with direct experience in Regulatory Affairs.
• Demonstrable experience of leading cross-functional project teams and change projects, including working within a multifunctional/geographical matrix.
• Demonstrable experience of analysing the data requirements of RA business processes and of managing regulatory data in line with the high standards required to maintain regulatory compliance and to support the growing RA business data demands.

Preferred:

• Extensive experience of the pharmaceutical industry with direct experience in Regulatory Affairs.
• Extensive experience of leading cross functional project teams and change projects, including working within a multifunctional and geographical matrix.
• Extensive experience of analysing the data requirements of RA business processes and of managing regulatory data in line with the high standards required to maintain regulatory compliance and to support the growing business process data demands.
• Experience with Parexel/Liquent’s Insight/Veeva regulatory information management suite of products.

• Knowledge of global (FDA, EMA, Health Canada and Japan) regulatory requirements.
• Knowledge of global industry initiatives and direction.
• Knowledge of industry regulatory standards (eCTD, CDISC, EVPRM, SPL, ISO IDMP, SPOR, RIM systems etc).
• Understanding of regulatory business processes: regulatory submission, CMC, product strategy, registration/regulatory data management..
• Understanding of the drug development process for generics, branded, and Non-Med product development a plus.
• Working knowledge of system and business process design and implementation a plus.

Sr Manager, RIM, Global Regulatory Operations

This incumbent

• Ensures that the review of CMC documentation is completed in timely & compliant manner as per Teva CORP standards and related Guidance’s.
• Review of Method Development/Validation Protocols & Reports, Stability Protocols & Reports received from various Teva contracting sites, R&D units, Method Development & Stability Testing Centres.
• Review of Instrument/Equipment Qualification records.
• Review of BMR.
• Ensures that the Product Quality Reviews / Annual Product Reviews for Teva products are completed in a timely and compliant manner as per Teva’s CORP Quality Management systems. PQR/APR compilation and approval must be well associated with the Teva Manufacturing Sites, Global Quality Units and Commercial affiliates to meet the targets and ensure compliance.
• Compilation of high quality Annual Product Reviews (APRs) / Product Quality Reviews (PQRs) for products manufactured at various manufacturing sites and retrieve data from the Quality and regulatory databases and system
• Liaising with third party contract manufacturers and QA/QC/Technical support personnel located globally for data collection and arranging responses.
• Recommend actions and professionally communicate to sites/ Quality units for continuous improvement in quality of products
  Receives guidance from Supervisor, Group Leader, Manager Global Quality Services, Associate Director Global Quality GBS, other Managers in Quality Strategy & Shared Services, EMSO Quality affiliates, Commercial Quality EU & IM, TGO sites

1. Review of CMC Documentation

• Review of Method Development / Validation protocols & reports.
• Review of Stability Study protocol, reports & grids.
• Review of Instrument / Equipment Qualification records.
• Review of Batch Manufacturing Records.
• Liaising with contracting Teva units and QA/QC personnels located globally for arranging required documents and query responses.
• Escalation of issues to Supervisor, Group Leader, Manager Global Quality GBS.
• Contemporaneous updation of SharePoint data base

1. Data requesting and Compilation of PQR’s

• Compilation of high-quality Annual Product Reviews (APRs) / Product Quality Reviews (PQRs) for products manufactured at various manufacturing sites and retrieve data from the Quality and regulatory databases and systems
• Liaising with third party contract manufacturers and QA personnel located globally for data collection required for compilation of APRs/ PQRs.
• Follow up with the CMO‘s for the receipt of data within time.
• Check quotation received from CMO and initiate PR/PO for QP’s approval.
• Once the data is received responsible for filling the PQR receipt checklist and scheduling the PQR in SharePoint.
• Escalation of PQR issues to Supervisor, Group Leader, Manager PQR Centre.
• Contemporaneous updation of SharePoint data base

1. Quality Management Systems

• Initiate the process of change controls and deviations
• Preparation of local SOP’s and its related documents.
• Participate in self-inspection process

1. Performance Management

• Participate in continuous process improvement projects to improve efficiency of the unit

1. Training

• Prepare the Training Materials for GMP training and on the job training.
• Imparts training on procedures as needed.

1. Miscellaneous Support

• Any other tasks assigned by the management for smooth functioning of the team

• 2 to 8 years of experience in QA / QC function in the pharmaceutical industry
• Master’s Degree in Pharmacy or other natural sciences or Bachelor Degree in Pharmacy or other natural sciences
• Basic knowledge on worldwide cGxP regulations
• Good English language skills, other language skills could be helpful
• Good communication skills
• Basic knowledge of Computerised Systems. Knowledge of Systems in TEVA´s IT landscape (TrackWise, SAP, LIMS, Global Insights, Glorya etc.) would be of advantage
• Basic understanding of manufacturing, QC and Contract manufacturing processes
• Engagement to drive improvements and ability to manage complexity
• Hands-on experience on Analytical Method development, Method Validation for API and FP of different analytical methods (e.g. Assay, impurities, dissolution etc.) & Stability Studies.
• Hands-on experience on Review of Instrument/Equipment qualification records.
• Basic knowledge / hands on experience of review of BMR.
• Basic knowledge / hands on experience on Product Quality Reviews.