Quality Assurance Special
1 week ago
**Location**: SVK PHARMA PVT LTD
**Industry**: Pharmaceutical Manufacturing - Formulations
**Experience**: 5-6 years (minimum) in QA for formulations
**Key Responsibilities**:
Preparation and review of Batch Manufacturing Records (BMRs) and speciation documents for all product types.
Authoring, reviewing, and controlling Standard Operating Procedures (SOPs) as per GMP and regulatory standards.Execution and management of Change Control procedures in alignment with QMS.End-to-end experience in:Drug Master File (DMF) documentationMethod Validation and Analytical TransferTMF (Technical Manufacturing File)Annual Product Quality Review (APQR)Preventive Maintenance coordination and compliance reviewManaging deviations, OOS/OOT, CAPAs, and risk assessments.Support for internal and external audits (regulatory and customer).Training junior QA staff and promoting quality culture on the shop floor.Collaboration with cross-functional departments: Production, QC, Engineering, RA.
Strong practical knowledge in:BMR review & speciation documentationSOP writing and controlChange Control systems and deviation handlingGMP, ICH, QMSExcellent understanding of regulatory expectations (USFDA, MHRA, WHO, etc.).
Effective communicator with a proactive and quality-focused mindset.
**Education**:B.Pharm / M.Pharm / B.Sc / M.Sc or equivalent in a related field.
Pay: ₹60,000.00 - ₹200,000.00 per month
Work Location: In person
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