Executive - QA

Lupin; India; On-site; INR 900,000 - 1,300,000; Full time

Job summary

Lupin is seeking an experienced IPQA/QC professional for its manufacturing site. You will ensure compliance with cGMP, perform line clearance and in-process checks, review batch records, support batch release, and manage CAPA and change controls.

The role involves self-inspection, participation in investigations, preparation of APQR, and coordination of eDMS and SAP-based documentation; Graduation in Pharmacy with 6-9 years of experience is required; strong SOP training is essential.

Qualifications

• 6-9 years of experience in quality assurance within pharma manufacturing.
• Graduation in Pharmacy with exposure to cGMP and QA processes.
• Experience in batch records review and manufacturing compliance.

Responsibilities

• Compliance to batch records instructions for various products.
• Ensure SOPs and cGMP compliance at shop floor.
• Prevent mix-ups, contamination and cross-contamination during all manufacturing stages via line clearance and continuous monitoring.
• Perform in-process checks at different stages and ensure compliance.
• Sampling at various stages as required.
• Stage-wise review of batch records and compliances for timely release.
• Prepare and execute process validation and cleaning validation/verification.
• Review master batch records and batch packing records in SAP.
• Participate in qualification and calibration activities.
• Prepare APQR periodically.
• Handle CAPA, change controls, OOS, OOT, incidents and deviations via QAMS.
• Coordinate and execute self-inspections and compile observations.
• Participate in investigations related to product/system failures.
• Promote cGMP awareness and SOP training among technicians.

Skills

cGMP knowledge

Line clearance

In-process checks

Batch release

CAPA

Change controls

OOS/OOT investigations

QAMS

Self inspection

IPQA

SOP training

Education

Graduation in Pharmacy

Tools

SAP

eDMS

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

Competencies

Requirements: