Officer
Lupin Ltd
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Job summary
Lupin Ltd in India seeks a Pharmacy graduate QA professional to ensure batch records compliance, SOP adherence and cGMP on the shop floor.
You will perform in-process checks, line clearance, sampling, process and cleaning validation, and review master batch records in SAP, with 2–4 years of relevant experience.
Qualifications
- Compliance with batch records and cGMP requirements
- Ensure SOP compliance on the shop floor
- Perform line clearance to prevent contamination
- Conduct in-process checks at various manufacturing stages
- Sampling as required
- Review batch records and facilitate timely releases
- Prepare and validate process and cleaning validation
- Review MBR and BPR in SAP
- Investigate product/system failures
- Train technicians on cGMP and SOPs
Responsibilities
- Compliance with batch records and cGMP requirements
- Ensure SOP compliance on the shop floor
- Perform line clearance to prevent contamination
- Conduct in-process checks at various manufacturing stages
- Sampling as required
Skills
Education
Tools
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.
2-4 years
Graduation in Pharmacy
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.
2-4 years
Graduation in Pharmacy
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