Enzene looking for QA Senior Executive

Enzene is a technology driven company based in Pune, India. We strive to harness disruptive innovation to enhance global health. Our aim is to provide, affordable, quality medicine for aiding lives with debilitating conditions. Enzene has invested in world class R&D infrastructure which allow access to technologies of the future. Enzene has end to end development platform from our own propriety CHO duos cell lines, to high throughput upstream and downstream platforms, comprehensive drug product development capabilities backed by state of the art advanced analytical technologies supports speedy development of pre-clinical and clinical drug candidates.

Post : Senior Executive QA (DSQA)

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.

Candidate Profile
• 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)

Additional Information
Department : Quality Assurance
Experience : 6 to 9 Years
Qualification : M.Sc / M.Pharm
Location : Pune, Maharashtra, India
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : QA - IPQA(DS)
End Date : 30th September 2026