Executive Job at Enzene Biosciences Ltd | Pharma Jobs in Pune | Apply Now
The Executive Job at Enzene Biosciences Ltd is a great opportunity for professionals exploring Pharma Jobs in Pune within the Quality Assurance domain. This role focuses on ensuring cGMP compliance at the shop floor for Drug Substance manufacturing through line clearance, documentation review, in-process oversight, and quality systems activities. If you are searching for an Executive Job in a reputed organization and looking to grow your career through Pharma Jobs in Pune, this opening at Enzene Biosciences Ltd offers strong exposure to regulatory compliance and DS shop floor QA operations.
Job Details
- Job Title: Executive / Senior Executive – QA (DSQA)
- Location: Pune
About the Company
The Executive Job at Enzene Biosciences Ltd is part of the Quality Assurance department supporting Pharma Jobs in Pune with a strong focus on cGMP compliance and regulatory readiness at the Drug Substance manufacturing shop floor. Enzene Biosciences Ltd operates under global regulatory guidelines and maintains robust quality systems for DS manufacturing operations.
Job Description
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.
Qualifications
- M.Sc / M.Pharm
- 2–9 years of experience in Quality Assurance for Drug Substance manufacturing
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, investigative, and problem-solving skills
- Effective communication and coordination with cross-functional teams
Regulatory Exposure
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USFDA, EMA, WHO, and other global regulatory guidelines (preferred)
