Glenmark Pharmaceutical Ltd, Baddi (H.P.) A manufacturing facility having approval from more than 25 different regulator authorities including USFDA, MHRA, ANVISA etc. The facility is equipped to manufacture multiple dosage forms and has state of the art manufacturing setup and Quality Control Lab.
Post : Manager - Quality Assurance (Technology Transfer & Regulatory Submission)
Reporting to : Senior Manager- QA
Key Responsibilities
• Provide clearance of technology transfer (Analytical).
• Support the transfer of products to other Glenmark sites or external parties.
• Review analytical reports for completeness and compliance with relevant standards.
• Submit documents for regulatory submissions and filings.
• Ensure review of Stability sample analysis, In-Process testing, Technology Transfer, and review/release of Exhibit Finished Product reports.
• Approve Stability trends to ensure product quality and consistency.
• Send Bio study, market samples, and testing samples to required destinations as per regulatory requirements and SOP.
• Prepare documents for product deficiency response and submit to regulatory affairs for product submission.
• Review and approve validation protocols/reports, stability protocols, technology transfer, and other master documents.
• Review of OOS ,OOT , LER’s and Laboratory Incidents for completeness, root cause evaluation present in submission batches.
• Coordinate with Regulatory Affairs and Research & Development for the submission of AND A. Coordinate for sending of clinical studies samples.
Key Competencies :
• Analytical thinking, attention to detail, strong communication skills, stakeholder management, project management, problem-solving abilities, organizational skills, knowledge of quality management systems & regulatory requirements.
Additional Information
Experience : 5+ year
Qualification : M.Pharm, B.Pharm, M.Sc
Location : Goa Plant
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Quality Assurance
End Date : 31st May 2024
Interested candidates can apply by sending their updated CV to Omkar.Parab@glenmarkpahrma.com with the subject line as “Application for Manager- Quality Assurance (Technology Transfer & Regulatory Submission), Goa”.
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