Senior Executive - QA - IPQA(DS)

Enzene Biosciences Ltd.; Pune District; On-site; INR 600,000 - 900,000; Full time

Job summary

Enzene Biosciences Ltd. in Pune is seeking a QA professional to perform line clearances on DS/DP shop floors, ensure in-process checks, and document GMP rounds.

You will review BMRs, validate protocols, manage SOPs, collect samples, and drive CAPA and change controls. Strong knowledge of cGMP and regulatory readiness is required; collaboration with cross-functional teams is essential.

Qualifications

• Experience with cGMP, QMS and regulatory requirements.
• Hands-on DS/DP shop floor QA activities.
• Familiarity with BMR review and documentation control.

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 and compliance.
• Review and approve process validation and cleaning validation protocols and reports.
• Review and manage SOPs and other shop floor protocols/reports.
• Coordinate collection and submission of samples per BMR, specs, 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.
• Strong knowledge of cGMP, QMS, and regulatory requirements.

Job description

Key Responsibilities

• Performmanufacturing line clearanceon the shop floor forDS activities.
• Ensure proper execution and compliance ofin-process checksduring manufacturing operations.
• Conduct routineGMP roundsat theDrug Substance facilityand document observations.
• Reviewonline batch manufacturing records (BMR)for accuracy, completeness, and compliance.
• Review and approveprocess validation protocols and reports,cleaning validation protocols and reports.
• Review and manageStandard Operating Procedures (SOPs)and other protocols/reports related to shop floor operations.
• Coordinatecollection and submission of samplesas per BMR, specifications, process validation, and stability protocols.
• Perform regularshop floor compliance roundsto ensure adherence tocGMPand follow up on corrective actions.
• Prepare and supportAnnual Product Quality Review (APQR/PQR)documents.
• Initiate and manageChange Control, Deviations, Incidents, and CAPA, including investigation support and timely closure.
• Participate inQMS investigationsand root cause analysis.
• Ensure continuouscGMP complianceand regulatory readiness at the shop floor.
• Performrisk assessmentsfor critical manufacturing and quality processes.
• Strong knowledge ofcGMP, QMS, and regulatory requirements
• Hands-on experience withDS/DP shop floor QA activities
• Understanding ofprocess validation, cleaning validation, and in-process controls
• Experience inBMR 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)