דרושים Opex Lean Specialist ב-טבע ב-הודו

• Perform initial problem determination (level 1) in support of scope of services with related hardware, software and services support.
• Provide in-scope technical advice and guidance, trouble shoot end users queries / issues and advise potential resolutions within specified KPIs and metrics.
• Handle service entitlement failures associated with requests for in-scope services.
• Assign records to other support groups, as and when required.
• Act as service desk's advocate when dealing with other support / resolver groups.
• Initiate the service outage procedure, update VRU status messages with outage information, as required.
• Process requests for password resets and manage the requests to satisfactory completion.
• Accurately log all interactions via established business processes and tools.
• Understand and contribute to the improvement of various performance metrics.
• Update inventory for software licenses, hardware and reporting.

• 1 -2 years' experience as a technical service desk agent
• Excellent logical reasoning, troubleshooting and problem determination skills
• Strong communication (verbal and written) skills
• Knowledge and experience with Remote takeover tools.
• Work in office is required (No work from home option)

First Line Manager

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.

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.

• 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.

• Responsible for Collection, compilation, analysis, and review of all data for APQR.
• Responsible for Processing and oversight of changes through the generation, justification, impact assessment, modification, review, approval, and implementation workflow.
• Responsible for Review/approval of all documentation associated with the process validation ,CPV & cleaning validation.
• Responsible for processing of documents through the generation, modification, review, and approval and archival of records.
• Responsible for review/approval of all documentation associated with the GMP equipment. This includes any Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) documents.
• Responsible for tracking, trending, and reporting of Quality Metrics for site, regional, and global review. Trending as required by SOP, Corp. Standards, and/or regulations.
• Responsible for Review/approval of all documentation associated with the establishment and configuration of a GMP computerized system. This includes all lifecycle documents.
• Responsible for Review of regulatory and quality compliance requirements and divisional policy, performance of gap assessments, and establishment or improvement of SOPs covering all areas of applicability.
• Quality support to Regulatory Affairs as it relates to updates/changes to Market Authorizations.
• Responsible for Management, tracking, and/or performance of GMP type training supporting plant performance and Quality Departmental training and hands on qualification.
• Responsible for Review/approval of the Validation Master Plan and all documentation associated with the validation or qualification of a process, system, equipment, facility, and/or the utilities associated with the site.

• B.sc/Msc in chemistry
• 4 to 10 years of experience
  

Manager Quality Systems

• Perform initial problem determination (level 1) in support of scope of services with related hardware, software and services support.
• Provide in-scope technical advice and guidance, trouble shoot end users queries / issues and advise potential resolutions within specified KPIs and metrics.
• Handle service entitlement failures associated with requests for in-scope services.
• Assign records to other support groups, as and when required.
• Act as service desk's advocate when dealing with other support / resolver groups.
• Initiate the service outage procedure, update VRU status messages with outage information, as required.
• Process requests for password resets and manage the requests to satisfactory completion.
• Accurately log all interactions via established business processes and tools.
• Understand and contribute to the improvement of various performance metrics.
• Update inventory for software licenses, hardware and reporting.

• 0 - 1 years' experience as a technical service desk agent
• Excellent logical reasoning, troubleshooting and problem determination skills
• Strong communication (verbal and written) skills
• Knowledge and experience with Remote takeover tools.
• Work in office is required (No work from home option)

First Line Manager

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.

• Minimum 1-4years of overall experience in Complaints handling,
• Bachelor’s degree of Pharmacy (B. Pharm) or Master’s Degree in Pharmacy (M. Pharm) and also MSC if candidate is fitting in criteria required
• 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
• Experience from regulated market preferred
• Shift: Night Shift (6 PM to 3 AM)
• Hybrid Working (3 Days working from office and 2 days working from home)

Sr Mgr Commercial Quality

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.

• Desire to make a change, even against many odds

• Detail oriented analytical and Problem Solving skills

• Strong Project management and presentation skills .

• Knowledge of Lean tools like VSM, OEE, 5S, SMED etc. Knowledge of application of statistical software like Minitab, JMP will be added advantage.

• Strong collaboration skills are required to coordinate activities

• Demonstrated effective communication and organizational (change management) skills

• Evidence of ability to teach, guide and mentor others and demonstrates leadership ability at different levels

• Inspiring trust through reliability, openness, acceptance, and consistency

• Displays confidence; can defend own perspective and support it with data

• Focused on business impact and actionable recommendations

• Certified Lean- Six sigma Black belt from reputed institute/organization

• Strong performer in current role and ambitious regarding his/her own career path

• Self-directed, stable and perseverant

• Willingness to learn

• Distinctive leadership; willing to propose tough/ unpopular decisions, but well respected by internal and external stake holders

• Batchlor degree in chemical engineering/ M.Sc. in chemistry.

• 5-10 years of experience in pharma / chemical manufacturing units in Production / OPEX / Tech transfer / MS&T