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Teva Pharmaceuticals
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Quality Specialist II

Quality Specialist II

Teva Pharmaceuticals

2 - 8 years

0 Lacs

karnataka

Posted:2 days ago| Platform: Shine logo

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Skills Required

qa qc method development equipment qualification deviations sops analytical method development method validation stability studies cmc documentation validation protocols stability study protocol instrument qualification batch manufacturing records data compilation quality management systems change controls gmp training product quality reviews

Work Mode

On-site

Job Type

Full Time

Job Description

Role Overview: You will be responsible for ensuring the timely and compliant review of CMC documentation, Method Development/Validation Protocols & Reports, Stability Protocols & Reports, Instrument/Equipment Qualification records, and BMR. You will also be involved in compiling high-quality Annual Product Reviews (APRs) / Product Quality Reviews (PQRs) for products manufactured at various sites, liaising with third party contract manufacturers, and recommending actions for continuous improvement in product quality. Additionally, you will participate in Quality Management Systems, Performance Management, Training, and provide miscellaneous support as needed. Key Responsibilities: - Review CMC Documentation - Review Method Development / Validation protocols & reports - Review Stability Study protocol, reports & grids - Review Instrument / Equipment Qualification records - Review Batch Manufacturing Records - Liaise with contracting Teva units and QA/QC personnel globally for document arrangement - Compile high-quality APRs/PQRs for manufactured products and retrieve data from databases - Follow up with third party manufacturers for data collection - Check quotations and initiate PR/PO for approval - Update SharePoint database contemporaneously - Initiate change controls and deviations process - Prepare local SOPs and related documents - Participate in self-inspection process - Participate in process improvement projects - Prepare Training Materials and provide GMP training - Perform any other tasks assigned by management Qualifications Required: - 2 to 8 years of experience in QA/QC function in the pharmaceutical industry - Masters Degree in Pharmacy or other natural sciences OR Bachelor Degree in Pharmacy or other natural sciences - Basic knowledge of worldwide cGxP regulations - Good English language skills - Good communication skills - Basic knowledge of Computerised Systems - Basic understanding of manufacturing, QC, and Contract manufacturing processes - Hands-on experience in Analytical Method development, Method Validation, and Review of Instrument/Equipment qualification records - Basic knowledge/hands-on experience of review of BMR - Basic knowledge/hands-on experience of Product Quality Reviews (Note: The additional details about the company were not included in the provided job description.),

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Teva Pharmaceuticals

Pharmaceutical Manufacturing

Tel-Aviv Petach Tikva

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Quality Specialist II