Website Enzene ltd
Post Name: Senior Executive – QA – IPQA(DS)
Job Description:
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
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)
