Executive/ Senior Executive- IPQA- DS

Job Title: Executive / Senior Executive QA (DSQA)

Department: Quality Assurance

Location: Pune

Experience: 29 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)