Hiring for Executive – QA (API exposure) at Lupin Limited.
🎓 M. Sc (Chemistry)
💰 up to INR 8.50 LPA
💼 8 to 10 Years
🌏 Pithampur, Indore, Madhya Pradesh
🏭 Pharmaceuticals
📋 Roles and Responsibilities
✅ Preparation of SOPs of QA, review of other departments’ SOPs.
✅ To perform batch release of API material and review of related documents.
✅ To prepare and review Quality Risk Assessment, Site Master File, Hold Time Study Protocol/Reports, and other study protocols/reports, Specifications, Stability Protocol, and Stability Report Data.
✅ Review of Validation Master Plan.
✅ To review the analytical method transfer protocol/report and method validation documents of the API.
✅ To ensure and handle the investigation of out-of-specification Results, OOT, Deviations, Product failures, and Market Complaints.
✅ To review Quality system documents such as Deviation, Change control, CAPA, OOS, OOT, re-processing, Re-work, market complaints, and market returns.
✅ To review Qualification Protocols/Reports of product, equipment, and facility.
✅ To Review of the Annual Product Quality Review.
✅ To review of Master Document, such as BPR, Test and Calibration Data Sheet, Test Procedures, and Microbiological Test Procedures.
✅ To collect, review, and submit documents to the RA Department for dossier preparation /Regulatory Submission.
📝 Interested candidates can share their resume at 📧 parichayindore@lupin.com.
Hiring for Officer – QA Doc Cell (API exposure) at Lupin Limited.
🎓 B.Sc. & B. Pharma
💰 up to INR 5.50 LPA
💼 2 to 6 Years
🌏 Pithampur, Indore, Madhya Pradesh
🏭 Pharmaceuticals
📋 Roles and Responsibilities
✅ Arrangement of documents and records in documents cell and timely tracking of documents for the effectiveness, submission, retrieval, discontinuation, obsoleting and destruction of the specific documents under the SOP guidance.
✅ Ensure retention of documents and records as per regulatory requirements.
✅ Ensure and monitor the document cell activity as per SOP and facility meets the GMP compliance level.
✅ Preparation and review of Specifications, Standard Test Procedure and Test data sheet such as Raw Material, Packaging Material, In- Process, Intermediate, API Finished and Finished products.
✅ Preparation and review of the SOP’s of Quality Assurance department.
✅ Initiation and review of change control, deviation and other quality system (QAMS system) documents. Tracking of QAMS events for closing and make sure the closure as per timeline.
✅ Issuance, Retrieval and Destruction of documents such as SOPs, Specification and Standard Test Procedure, Logbooks and all other documents.
✅ Documents updating in ‘Omni Docs’ as per SOP.
✅ Master BMR /BPR linking /delinking and printing from SAP.
✅ Preparation of master plan (Master Inspection Characteristic Report) in SAP.
✅ Preparation and review of E-TDS, SAP Annexure’s and related activities i.e. Merging, Uploading, Linking /delinking and Printing in SAP.
✅ E-TDS Merging, Uploading, Linking and Printing in SAP.
✅ Numbering of all type of QAMS document and logging into respective records/system.
✅ To perform the e-DMS Activity such as QA Authorizer.
📝 Interested candidates can share their resume at 📧 parichayindore@lupin.com.
✅ Planning, tracking and completing cleaning validation and verification study: Preparation of protocol (validation and verification) and acceptance criteria calculation, Compilation of data and preparation of report.
✅ Coordination with third parties for outsourced activities such as Temperature mapping, HVAC qualification, sterilization validation etc.
✅ Coordination with other departments for validation activities such as QA, Warehouse, Production, Engineering, Purchase, Process/Packaging development etc.
✅ Ensuring compliance of Regulatory and CGMP norms for all validation related activities.
✅ To perform, plan and completed validation / qualification activities within requalification frequency as per VMP / product requirement.
✅ Tracking and handling of QAMS activities such as Change control, Deviation, CAPA as applicable.
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