Quality Sr Specialist

Bangalore, Karnataka
Permanent
Full-time

6 mins ago

Who we areTogether, we're on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It's a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world's leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization's Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we're always looking for new ways to continue making a difference, and new people to make a difference with.The opportunityThis incumbentEnsures 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 systemLiaising 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 productsReceives 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 sitesHow you'll spend your day

Review of CMC Documentation -

The owner of the function

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
Data requesting and Compilation of PQR's
The owner of the function

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
Quality Management Systems

The owner of the function

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

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

Your experience and qualifications

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.

Teva's Equal Employment Opportunity CommitmentTeva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.

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