Who we are Together 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 chance 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 How you ll spend your day 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 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 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 Performance Management Participate in continuous process improvement projects to improve efficiency of the unit Training Prepare the Training Materials for GMP training and on the job training Imparts training on procedures as needed Miscellaneous Support Any other tasks assigned by the management for smooth functioning of the team 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 TEVAs 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 Commitment Teva 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

📌 Quality Specialist Ii (Bengaluru)
🏢 Teva Pharmaceuticals
📍 Bengaluru