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Teva Pharmaceuticals
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Quality Sr Specialist - QA - TAPI

Quality Sr Specialist - QA - TAPI

Teva Pharmaceuticals

4 - 10 years

0 Lacs

gwalior madhya pradesh

Posted:2 days ago| Platform: Shine logo

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Skills Required

quality assurance compliance active pharmaceutical ingredients data analysis process validation regulatory affairs validation chemistry good manufacturing practice gmp standard operating procedures sops

Work Mode

On-site

Job Type

Full Time

Job Description

As a Quality Sr Specialist at Teva Pharmaceuticals, you will play a crucial role in ensuring the quality and compliance of active pharmaceutical ingredients (APIs). With over 80 years of experience in the generic API industry, Teva Pharmaceuticals is a trusted global supplier supporting 80% of the top 50 global pharmaceutical companies. Your contributions will directly impact the timely introduction of new products to the market, solidifying Teva's position as a leader in the industry. Key Responsibilities: - Collect, compile, analyze, and review all data for Annual Product Quality Review (APQR). - Process and oversee changes through the entire workflow, including generation, justification, impact assessment, modification, review, approval, and implementation. - Review and approve all documentation related to process validation, Continued Process Verification (CPV), and cleaning validation. - Manage documentation processes, including generation, modification, review, approval, and archival of records. - Review and approve all documentation associated with Good Manufacturing Practice (GMP) equipment, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) documents. - Track, trend, and report Quality Metrics for site, regional, and global review as per SOP, Corporate Standards, and regulations. - Review and approve all documentation related to the establishment and configuration of a GMP computerized system, covering all lifecycle documents. - Review regulatory and quality compliance requirements, conduct gap assessments, and establish or improve Standard Operating Procedures (SOPs) across applicable areas. - Provide quality support to Regulatory Affairs for updates/changes to Market Authorizations. - Manage, track, and perform GMP type training to support plant performance and Quality Departmental training and qualification. - Review and approve the Validation Master Plan and all documentation related to the validation or qualification of processes, systems, equipment, facilities, and utilities at the site. Qualifications: - Bachelor's or Master's degree in Chemistry (B.Sc/M.Sc). - 4 to 10 years of relevant experience in the pharmaceutical industry. Join Teva Pharmaceuticals as a Quality Sr Specialist and be part of a team dedicated to upholding the highest standards of quality and compliance in API manufacturing. Apply now to make a meaningful impact in the pharmaceutical industry.,

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Teva Pharmaceuticals

Pharmaceutical Manufacturing

Tel-Aviv Petach Tikva

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Quality Sr Specialist - QA - TAPI