דרושים Quality Control Technician - Tapi 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

• 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

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.

Position responsibilities include Quality oversight for Manufacturing, Packaging and Laboratory Operations to ensure a mature culture of quality, compliance with regulatory requirements and quality of products.

This oversight includes but is not limited to the establishment and execution of procedure; Establishment Licensing, Quality on the Floor activities including audit and release; handling of laboratory, deviation and complaint investigations; CAPA Creation and implementation; trending and metrics, compliance with validation requirements; verification that equipment, facility and utility systems are maintained in accordance with established requirements.

Lead the development, standardization, implementation, monitor effectiveness and continuous improvement of Quality Systems, global and local compliance programs, industry practices, and corporate quality initiatives. Influence quality and compliance initiatives to implement robust and proactive process improvement programs within a strong quality culture to align and demonstrate compliance to Good Manufacturing Practices

• Leads the Quality organization on site including Quality Control, Microbiology, Quality Compliance, Quality Systems and Quality Assurance Operations.
• Ensure a current Quality Management System is in place and continuously improved
• Ensure products are manufactured, released and distributed in accordance to cGMP requirements and registered specifications.
• Most senior professional and independent decision maker authority on product quality and potential market actions
• Assess and Mitigate Risks-- Identify quality risks and define proactive mitigations, to ensure the products are safe and effective before they reach the market. Work with the business to assure compliant and reliable supply
• Design and Implement the Site Quality Program—Collaborate with the Site GM and Corporate Quality to create, implement, monitor and update the site quality program.
• Manage Quality Data--Oversee the delivery of necessary data to site managers and supervisors, Corporate Quality and other internal and external stakeholders, to support the achievement of Quality objectives and ensure compliance
• Direct Quality Control-- Oversee the laboratory activity, including analytical site transfers, testing and approval or rejection of raw materials, packaging materials, in process materials and finished products for the site
• Promote a Sustainable Culture of Quality---Create, develop and maintain a culture of enhancing quality throughout the entire site operation. Create a space where people can speak openly and are encouraged to present new ideas to improve quality
• Maintain strong partnership with site leadership team
• Strategic partner in the site leadership team, with Supply Chain, Project Management, R&D, MS&T and Commercial to ensure project timelines and objectives are met
• Provide effective Quality leadership during internal, customer and Health Authority inspections
• Ensure that Quality KPIs are meeting pre-defined targets, Ensures CAPA commitments are implemented in a timely manner and its effectiveness is monitored periodically
• Plans, manages and monitors the annual Quality Operations budget and all its resources and employees. Ensure the performance and utilization of resources to provide maximum efficiency to the organization.

• Required – bachelor’s degree in chemistry, Biology, Pharmacy
• Preferred - Master or equivalent degree in Chemistry, Biology or Pharmacy

Key Requirements:

• Minimum of 10 years pharmaceutical manufacturing site quality operations and leadership experience, including:
  • Deep knowledge of cGMP requirements of local and major international authorities like EMA and US FDA for products and process,
  • High level of understanding of manufacturing, packaging, technology transfer, cGMPs, EU, ICH guidelines as well as CMC content of regulatory submissions,
  • Deep knowledge of chemical/pharmaceutical production operations/ lifecycle, production equipment/ validation and relevant technologies and product types,
  • Strong understanding and experience in Data Integrity and Compliance
  • Experience preparing and/ or leading regulatory authority GMP
  • Deep knowledge of Quality Systems
• Proven successful track record of leading organizational change to improve efficiency
• Experience leading, inspiring and coaching large teams
• Experience developing and implementing and continuously improve existing and new, efficient, and effective business processes
• Must have adequate knowledge of Quality best practices
• Must have adequate practical knowledge of pharmaceuticals manufacturing and/ or control
• Must have adequate practical knowledge of analytical techniques and microbiological principles
• Must have practical knowledge of pharmaceutical cross functional operations (e.g., Supply Chain, Engineering), product and tech transfer
• Must have practical knowledge on lean manufacturing/ lean QC and OPEX tools
• Good knowledge of environmental, health and safety requirements for laboratories and quality operations.

• Is responsible receiving, categorizing, trending, logging complaints for US market and coordinating the return of the complaint Samples for product quality related complaints from customers.
• This includes handling of complaints reported by US customers (patient, doctors, pharmacist, HCP or any other customers who use or handle Teva products) via live phone call (90%), email and voicemail etc.
• QAS team member need to be logged in Avaya Phone application between 6:30 PM IST (9:00 AM EST) to 2:30 AM IST (5:00 PM EST) to receive live phone calls related to complaints handling from US customers.
• The received complaints are processed in TrackWise application including classification into multiple categories (critical/non-critical) and also sending notifications to respective manufacturing /packaging sites located globally requesting investigation.
• Additional responsibilities include completion training in LMS (QAS process related) and STUDIUM tasks, handling reconciliation activities related to PV, complaint samples returned and participate in team meetings.
• Phone Etiquettes and Customer Service Skills:
  1. Positive Customer relationships with productive interactions related to Complaint issue, Gain better understanding of the issue, obtaining more information. Provide update on investigation status. Coordinating and checking the availability of Complainant Sample for return to investigating sites3. Strong communication skill in English language
  4. Patience and Empathy towards customers
  5. Attention to detail and problem-solving skills
  6. Multitasking ability

• Complaint Processing:
  Performs the functions associated with receiving, trending, logging, and coordinating the return of the complaint samples for product quality related Complaints. This includes complaints received via live phone call, email, and internet.
  Utilize knowledge and experience from processing of live complaint calls to lead by example.
• Assists QAS Intake team management in handling of QAS Intake team activities:
  Serves as a Subject Matter Expert on all In-Take Team complaint processes and scenarios and assists QAS employees to ensure compliance with Quality Assurance Services Standard Operating Procedures and Work Instructions.
  Collaborate with QAS team to discuss and calibrate on different complaint scenarios on how records should be handled during weekly team meeting.
• Participate and contribute to the continuous improvement activities of the QAS group:
  Participate in the continuous improvement of the QAS Group to drive operational excellence by performing a variety of tasks and projects to increase compliance, efficiencies and effectiveness of actions within the Group.

• Bachelor of Science Degree in a scientific field preferably, Pharmacy, Chemistry, Micro-Biology, Life sciences, etc.
• Understanding of US Code of Federal Regulations (CFR), Current Good Manufacturing Practices (cGMP) but not mandate
• Understanding of Product Quality related Complaints and Adverse Events; Deviations/Investigations/Root Cause Analysis, CAPA;
• Data Integrity and TrackWise but not mandate.
• Excellent written and verbal communication skills in English Language
• Flexibility to work in continuous permanent night (6:30 PM to 2:30 AM IST)Availability to take phone calls with external customers continuously during the US business hours.

• Carrying out dispensing activities as per applicable procedure.
• Carrying out process and sampling activities during the production of Intermediate /API’s according to approved batch cards.
• Responsible for recording the observations of reaction parameters on the batch card as per approved procedure.
• Filling of all the batch cards (production cleaning) as per approved instructions.
• Ensure verification of pH meters and weigh balances as per applicable procedures.
• Maintain work procedure, safety precaution and cGMP.
• Contributes to the development of new concepts, techniques, and standards including expert knowledge of cGMP standards .
• Coordination of production tasks to meet assigned schedule
• Knowledge of Liquide chromatography Operations.

• 3-5 Years – M.SC
  0.5 to 3 years - B.Tech / B.E (Chemical)
• 24/7 Shift

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.