Officer - Quality Assurance

Lupin; Sikkim; On-site; INR 700,000 - 950,000; Full time

Job summary

Lupin Ltd. in India is seeking a Compliance Specialist to ensure adherence to cGMP and SOPs on the shop floor, with emphasis on line clearance and contamination prevention. In-process checks and sampling across products will be routine, plus batch record review to support timely releases.

The role requires 2–4 years of manufacturing experience and a Pharmacy degree. You will review master batch records in SAP, participate in investigations, and train technicians on GMP practices.

Qualifications

• 2-4 years of experience in pharmaceutical manufacturing.
• Graduation in Pharmacy.
• Compliance with cGMP and SOPs.

Responsibilities

• Ensure SOPs and cGMP requirements on the shop floor are followed.
• Maintain line clearance and monitor the process to prevent contamination.
• Perform in-process checks at various manufacturing stages.
• Conduct sampling as required during production.
• Review batch records to ensure compliance and enable timely release.
• Assist in process validation, cleaning validation, and cleaning verification.
• Review master batch records and batch packing records in SAP.
• Participate in investigations related to product or system failures.
• Train technicians on GMP practices and reinforce cGMP awareness.

Skills

Line clearance

cGMP knowledge

SOP compliance

In-process checks

Sampling

Batch records

Process validation

Investigations

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 investigation related to product / system failure.
• Ensuring the awareness of cGMP and its requirement to the technicians/concerns through continuous interaction/SOP training.

Work Experience

2-4 years

Education

Graduation in Pharmacy