Executive Jobs at Enzene Biosciences | Chemistry Candidates Apply Now
Are you looking for Executive Jobs in Quality Assurance within the pharmaceutical industry? Enzene Biosciences Ltd is hiring Executive / Senior Executive – IPQA (Drug Substance) professionals in Pune. This opportunity is ideal for candidates seeking MSc Chemistry Jobs and advanced Chemistry Jobs with strong exposure to cGMP, shop floor QA operations, and global regulatory standards.
About Enzene Biosciences
Enzene Biosciences Ltd is a leading biopharmaceutical company specializing in biologics manufacturing and development. Known for its strong compliance culture and innovation-driven approach, Enzene offers excellent career opportunities for professionals looking to build successful careers in Executive Jobs, MSc Chemistry Jobs, and advanced Chemistry Jobs within the pharmaceutical and biotechnology industry.
- 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 on 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, investigative, and problem-solving skills.
- Effective communication and coordination with cross-functional teams.
Regulatory Exposure
USFDA, EMA, WHO, and other global regulatory guidelines (preferred).
