QA (IPQA/QMS/Qualification Validation)

Candidate should have good experience of IPQA Activities of OSD unit. Good exposure on IPQA instruments and should have sound knowledge of QMS like- Incidents, Change control, Deviations etc

Key ResponsibilitiesIn-Process Quality Assurance (IPQA):Monitor and ensure compliance during manufacturing and packing operations.Conduct routine checks and validations to maintain product quality.Line Clearance Activities:Perform and document line clearance before batch initiation and between product changes.Ensure adherence to GMP and prevent...

Job Responsibilities – QA OfficerReview and approve batch manufacturing records (BMRs) and batch packaging records (BPRs).Prepare, issue, and control SOPs, logbooks, and controlled documents.Ensure all documentation is maintained as per Good Documentation Practicesand ALCOA+principles.Handle deviations, CAPA, OOS/OOT investigations, and change...

Implement cGMP as per regulatory requirement to ensure business sustainability. Implement QMS system for adherence of process & product compliance through digitization platform. Conduct Qualification & Validation of equipment, instrument & processes Required Candidate profileM.Sc.(Chemistry) with 7+yrs experience in Quality Assurance of a Pharmaceutical...

Process Validation:Plan and execute process validation activities for sterile injectable products as per cGMP and regulatory expectations.Prepare and review validation protocols and reports, ensuring compliance with internal SOPs and global regulatory guidelines (e.g., USFDA, EU-GMP, WHO).Cleaning Validation:Develop and implement cleaning validation...

Process Validation:Plan and execute process validation activities for sterile injectable products as per cGMP and regulatory expectations.Prepare and review validation protocols and reports, ensuring compliance with internal SOPs and global regulatory guidelines (e.g., USFDA, EU-GMP, WHO).Cleaning Validation:Develop and implement cleaning validation...

Candidate should have good exposure of Cleaning Validation. Should be familiar with Risk Assessment approach and current regulatory requirements. Should have exposure of softwares like Trackwise, eDMS etc.

Officer Job Description Join Lupin Limited's dynamic Quality division as an Officer within our Validation department based in Pithampur. In this pivotal role, you will take charge of the cleaning validation activities for our API and Formulation facilities. Your responsibilities will encompass comprehensive management and execution of validation...

Customer Complaints, Corrective & Preventive Actions (CAPA), Sustainability of QMS (Deviations, Change control, OOS & Incident reporting). Regulatory Compliance, Support to New Product Development, Cost Optimization Measures, Handle Customer audits Required Candidate profileM.Sc.(Microbiology) with 12+yrs experience in Quality Assurance function of a...

Role & responsibilities :Review of all QMS documents related to regulatory submissionsPrepare status of all documents related to submissionCo-ordinate with all stakeholders of plant for collection of documentsProvide all regulatory documents to HO-RA for submission.Evaluation of change control, deviations and out of specifications.Review of specifications,...