Pharma QA Job at Enzene Career | M Pharm Eligible – Apply
Looking for a pharma QA job in a fast-growing pharmaceutical company? Enzene Career is hiring for the position of Executive / Senior Executive – DSQA (Drug Substance Quality Assurance). This role is ideal for M Pharm graduates who want to build a strong career in quality assurance, GMP compliance, and pharmaceutical manufacturing operations. If you have experience in shop floor QA activities, documentation review, and regulatory compliance, this opportunity offers excellent career growth in the pharmaceutical quality domain.
- Job Title: Executive / Senior Executive – DSQA (Drug Substance Quality Assurance)
- Department: Quality Assurance
About the Company
Enzene Biosciences is a leading biopharmaceutical organization focused on delivering high-quality, affordable biologics and innovative healthcare solutions. Through its advanced manufacturing and research capabilities, Enzene ensures global standards in drug development and production. A pharma QA job at Enzene Career provides professionals the opportunity to work in a GMP-driven environment, contributing to high-quality drug substance manufacturing and global regulatory compliance.
Job Description
In this pharma QA job at Enzene Career, the Executive / Senior Executive – DSQA will ensure strong cGMP compliance across drug substance manufacturing operations. The role involves shop floor QA activities such as line clearance, in-process checks, GMP rounds, and batch manufacturing record (BMR) review. You will support process and cleaning validation, SOP management, and sampling activities while ensuring accurate documentation and quality compliance. The role also includes handling deviations, change control, CAPA, and investigations, along with contributing to APQR/PQR preparation. Overall, this position ensures continuous quality compliance, regulatory readiness, and adherence to GMP standards in drug substance manufacturing.
Key Responsibilities
- Perform manufacturing line clearance for drug substance operations.
- Monitor and ensure compliance with in-process quality checks.
- Conduct routine GMP shop floor audits and document observations.
- Review batch manufacturing records (BMR) for accuracy and compliance.
- Review process validation and cleaning validation documents.
- Manage SOPs and quality documentation related to manufacturing operations.
- Coordinate sampling activities as per BMR and validation protocols.
- Conduct regular compliance rounds and ensure corrective actions.
- Prepare Annual Product Quality Review (APQR/PQR) reports.
- Handle Change Control, Deviations, CAPA, and incident investigations.
- Participate in root cause analysis and QMS investigations.
- Ensure continuous GMP compliance and regulatory readiness.
- Perform risk assessments for critical manufacturing processes.
Eligibility Criteria
- Education: M Pharm
- Experience:3 – 9 Years
Required Skills
- Strong knowledge of cGMP & Quality Management Systems (QMS)
- Experience in drug substance QA / shop floor operations
- BMR review and documentation control
- Process validation & cleaning validation knowledge
- Change control & deviation management
- CAPA and root cause analysis
- GMP audit & compliance monitoring
- Strong analytical and problem-solving skills
- Effective communication and coordination skills
- Knowledge of USFDA, EMA, WHO guidelines (preferred)
Why Join Enzene Career?
This pharma QA job at Enzene Career offers an excellent opportunity to work in a regulated GMP manufacturing environment with exposure to global quality systems. You will gain hands-on experience in drug substance quality assurance, regulatory compliance, and advanced pharmaceutical manufacturing processes. Enzene provides a strong platform for career growth in quality assurance with continuous learning and professional development opportunities.
