Executive/ Senior Executive- IPQA- DS

Job Title: Executive / Senior Executive – QA (DSQA)Department: Quality AssuranceLocation: Pune Experience: 2–9 YearsQualification: M.Sc / M.Pharm Job Purpose To ensure cGMP compliance at the shop floor for Drug Substance (DS) manufacturing through effective line clearance, documentation review, in-process oversight, and quality systems activities. Key Responsibilities Perform manufacturing line clearance on the shop floor for DS activities.Ensure proper execution and compliance of in-process checks during manufacturing operations.Conduct routine GMP rounds at the Drug Substance facility and document observations.Review online batch manufacturing records (BMR) for accuracy, completeness, and compliance.Review and approve process validation protocols and reports, cleaning validation protocols and reports.Review and manage Standard Operating Procedures (SOPs) and other protocols/reports related to shop floor operations.Coordinate collection and submission of samples as per BMR, specifications, process validation, and stability protocols.Perform regular shop floor compliance rounds to ensure adherence to cGMP and follow up on corrective actions.Prepare and support Annual Product Quality Review (APQR/PQR) documents.Initiate and manage Change Control, Deviations, Incidents, and CAPA, including investigation support and timely closure.Participate in QMS investigations and root cause analysis.Ensure continuous cGMP compliance and regulatory readiness at the shop floor.Perform risk assessments for critical manufacturing and quality processes. Skills & Competencies Strong knowledge of cGMP, QMS, and regulatory requirementsHands-on experience with DS/DP shop floor QA activitiesUnderstanding of process validation, cleaning validation, and in-process controlsExperience in BMR review and documentation controlGood analytical, investigation, and problem-solving skillsEffective communication and coordination with cross-functional teams Regulatory Exposure USFDA, EMA, WHO, and other global regulatory guidelines (preferred)

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