Job Title
: Senior Executive QA (DSQA)

Department:
Quality Assurance

Experience:
6 to 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 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
- Valuable analytical, investigation, and problem-solving skills
- Effective communication and coordination with cross-functional teams

Reg

📌 Senior Executive (Pune Division)
🏢 Enzene Biosciences
📍 Pune Division