Executive - QA

Lupin Ltd; Sikkim; On-site; INR 900,000 - 1,200,000; Full time

Job summary

Lupin Ltd is seeking a QA/QC professional to ensure cGMP compliance and batch records integrity on the shop floor in India. You will lead line clearance, in-process checks, and sampling across multiple products, enabling timely release and strong CAPA management.

The role requires 6–9 years of experience in pharmaceutical QA with a pharmacy degree. SAP experience and IPQA involvement are essential for successful batch release and regulatory readiness.

Qualifications

• 6-9 years of work experience in QA/Production compliance.
• Must ensure compliance with SOPs and cGMP on shop floor.
• Experience in batch records review and facilitating timely release.

Responsibilities

• Ensure compliance to batch records and cGMP across products.
• Maintain line clearance and continuous process monitoring to prevent mix-ups or contamination.
• Perform in-process checks at various stages of manufacturing.
• Conduct sampling at defined stages or as required.
• Review master batch manufacturing records and batch packing records in SAP.
• Participate in qualification, calibration, and APQR activities.
• Handle CAPA, change controls, OOS, OOT and deviations through QAMS.
• Coordinate self-inspections and document observations.
• Engage in IPQA activities and batch release processes.

Skills

cGMP compliance

Batch records review

Line clearance

In-process checks

Sampling

APQR preparation

CAPA handling

Change controls

Self-inspection

IPQA activities

Education

Graduation in Pharmacy

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

Competencies

• 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.