Executive - QA

Lupin; Mangan; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Lupin is seeking an experienced QA/IPQA professional to ensure cGMP compliance across manufacturing lines. The role involves batch records review, in-process checks, CAPA handling, and support for batch release activities.

The candidate will coordinate self-inspections, investigations, and qualification activities while maintaining strict adherence to SOPs and QMS requirements within the GMP framework.

Qualifications

• Ensure SOPs and cGMP are followed on the shop floor.
• Review batch records and support process validity activities.
• Handle CAPA, change controls, OOS/OOT, deviations and investigations.
• Coordinate access and approvals for batch release and IPQA processes.

Responsibilities

• Ensure compliance with batch records and cGMP on shop floor.
• Perform in-process checks at different stages of manufacturing.
• Manage CAPA, change controls, OOS, OOT, deviations and investigations through QAMS.
• Coordinate and execute self-inspections and document observations.
• Participate in batch release activity and eDMS activities.
• Review master batch manufacturing and batch packing records in SAP.
• Participate in qualification and calibration activities.
• Prepare and compile process validation, cleaning validation and verification.
• Train technicians on cGMP and SOP requirements.

Skills

cGMP

Batch records

In-process checks

CAPA

OOS/OOT

IPQA

Laboratory incidents

Education

Graduation in Pharmacy

Tools

SAP

Job description

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

Requirements: