Executive -QA

Lupin; Mangan; On-site; INR 700,000 - 1,300,000; Full time

Job summary

Lupin is seeking a seasoned IPQA/QA professional with 6-9 years of experience in pharma manufacturing to ensure cGMP compliance across batch records, in-process checks, line clearances and product release at the shop floor.

You will review master batch records, participate in process validation, CAPA handling, and self-inspections, while coordinating with QA/QMS teams to maintain quality and regulatory adherence.

Qualifications

• Graduation in Pharmacy with QA exposure.
• Experience in GMP environments and batch records.
• Familiarity with QA/QC processes.

Responsibilities

• Ensure batch records follow instructions and compliance.
• Maintain SOP and cGMP compliance at shop floor.
• Prevent mix-ups and contamination; execute Line Clearance.
• Conduct In-process Checks at manufacturing stages.
• Perform Sampling as required.
• Review batch records to facilitate timely release.
• Prepare and execute process and cleaning validations.
• Review master batch and batch packing records in SAP.
• Contribute to IPQA activities and calibration.
• Prepare APQR periodically.
• Manage CAPA, change controls, OOS/OOT and deviations via QAMS.
• Coordinate self-inspections and report observations.
• Investigate product/system failures.
• Train technicians on cGMP requirements.
• Participate in Batch Release Activity.
• Handle eDMS activities.
• Engage in all IPQA activities.

Skills

In-process checks

Line clearance

cGMP compliance

Batch release

CAPA management

Deviation handling

QA documentation

Education

B.Pharm

Tools

SAP

Job description

Job Description

• Compliance to the instructions given in Batch records of various products.
• Ensuring the compliance of the SOPs and cGMP requirements at shop floor.
• Ensuring no mix-ups, contamination and cross contamination of the products during all stages of manufacturing means of "Line Clearance" and continuous monitoring the process.
• Performing "In-process Checks" at different stages of manufacturing for various products and ensuring the compliance.
• "Sampling" at different stage of manufacturing or as per the requirement.
• Stage wise review of batch records and compliances if any, to facilitate timely release.
• Preparation, execution and compilation of process validation (Process performance qualification) and cleaning validation & cleaning verification.
• Review of master batch manufacturing record and batch packing record in SAP
• Active participation in execution of Qualification and calibration activity.
• Periodic review and preparation of APQR.
• Handling of CAPA, Change controls, OOS, OOT, Laboratory Incidence, Market complaint & Deviations through QAMS.
• Co-ordination & execution of Self Inspection and compilation of self-inspection observations.
• Active participation in investigation related to product / system failure.
• Ensuring the awareness of cGMP and its requirement to the technicians/concerns through continuous interaction/SOP training.
• Active Participation in Batch Release Activity.
• Handling eDMS activities.
• Active participations in all the IPQA activities.

Work Experience

6-9 years

Education

Graduation in Pharmacy