Executive/ Senior Executive- IPQA- DS

Job Title: Executive / Senior Executive – QA (DSQA)

Department: Quality Assurance

Location: Pune

Experience: 2–9 Years

Qualification: 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 requirements - Hands-on experience with DS/DP shop floor QA activities - Understanding of process validation, cleaning validation, and in-process controls - Experience in BMR review and documentation control - Good analytical, investigation, and problem-solving skills - Effective communication and coordination with cross-functional teams

Regulatory Exposure

- USFDA, EMA, WHO, and other global regulatory guidelines (preferred)