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Development QA-Manager / Sr.Manger-Formulation

10 - 15 years

0 - 2 Lacs

Bengaluru Visakhapatnam Hyderabad

Posted:3 months ago| Platform: Naukri logo

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Skills Required

chemistry analytical development project management analytical process development methods ipqa regulatory specifications ra analytical method validation qbd qc process validation qms quality assurance design formulation pharmacy doe formulation development

Work Mode

Work from Office

Job Type

Full Time

Job Description

• Ensure compliance with Stage Gate and Design QA procedures. • Coordination between different stake holders – R&D, QC, QA, RA, Project Management for effective Stage Gate reviews and clearances of Stages. • Review PDRs, Scale up reports including Lab Note books • Participate in designing DOE trials in line with Process • Review Scale up protocols, Exhibit protocols, Process Validation protocols and reports • R&D IPQA • R&D procedural compliances – Qualifications, Calibrations, RLD Management, Stability Management • Responsible for deviation, investigation related to R&D. • Responsible for specification/STP review. Review and clearance of Analytical Method Validations • R&D Documentation Management -Issuance and retrieval • Responsible for clearing Formulation Projects for Scale up and Exhibit batches.

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Pharmaceutical Manufacturing

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