Hiring for Officer – Packaging Development at Lupin Limited.
- B. Pharma / Any other relevant to Packaging Development
- 2 to 7 Years
- Pithampur, Indore, Madhya Pradesh
- Pharmaceuticals
Roles and Responsibilities:
Should have knowledge of Oral solid, Oral contraceptive Dosage form packaging process and technology knowledge of packing competent.
Should be well versed With the Development of Primary. secondary, and tertiary packaging material for Oral solid dosage form.
Should have awareness of regulatory guidance for USA/EU and other regulatory markets.
Execution of Development, Scale up, exhibit batches,
Review Of commercial, Exhibit and intended filing documents (i.e. BPR. Specifications, Equivalency report)
Transpiration Protocol and Reports.
Should have good communication and writing skills and aware of Good Documentation Practices.
Should have well versed With SAP handling and Quality system software.
Hiring for Officer / Executive – Quality Control (Nasal exposure) at Lupin Limited.
- B. Pharma / M.Sc
- 2 to 10 Years
- Pithampur, Indore, Madhya Pradesh
- Pharmaceuticals
Roles and Responsibilities:
Knowledge of HPLC/GC and others routine instruments of QC.
Expertise of pharmaceutical quality system (QAMS).
Analysis of Nasal & derma formulation. In-process/FP/SS. Working as QC analyst.
Understanding of Data Integrity, GMP, laboratory instrument software 21 CFR.
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.
How to Apply:
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.
Apply: parichayindore@lupin.com