Lupin Recruitment -Send Resume To Hr mail

Role & responsibilities

Hiring for Executive – Quality Assurance (Documentation Cell Management) at Lupin Limited.

🎓 B. Pharma / M.Sc

 💰 up to INR 10 LPA

 💼 Min 8 Years Experience (Documentation Cell Management)

 🌏 Pithampur, Indore, Madhya Pradesh

 🏭 Pharmaceuticals

 📋 Roles and Responsibilities

✅Good Documentation Practices (GDP): Understanding and applying ALCOA++ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available).

✅Data Integrity: Implementing practices to ensure the accuracy and consistency of data throughout its lifecycle.

✅Operating Procedures: Managing the archival, issuance, distribution, and tracking of master documents and records.

✅Master Document Preparation: Creating and managing documents like Site Master File, Batch Manufacturing Records (BMR), and Batch Packaging Records (BPR), including uploading to software systems and sharing with external parties.

✅Document Distribution Control: Overseeing the distribution of documents to departments, other sites, and vendors as needed.

✅Electronic Document Management Systems (e-DMS): Utilizing systems like SAP and Artwork Management for document and record management.

✅QUMAS: Accessing, revising, and uploading documents/records in QUMAS.

✅Reprint Issuance: Issuing reprint annexures and pages for executed batch documents for commercial and exhibit batches.

✅Master Batch Documents: Linking, printing, and releasing master batch documents and e-Test Data Sheets.

✅Certificates: Preparing Certificates of Analysis and Certificates of Conformance.

✅Logbooks: Issuing and retrieving logbooks for all departments and controlling copies of documents.

✅SAP Document Management: Accepting documents in SAP, printing labels, affixing, and archiving documents at designated locations.

✅Regulatory Submission: Collecting, scanning, and submitting documents to Regulatory Affairs for dossier preparation and submission.

✅Document Archival: Controlling and archiving documents submitted to external warehouses and maintaining traceability until destruction.

✅Standard Operating Procedures (SOPs): Preparing and reviewing SOPs.

✅Retention Sample Room: Managing the retention sample room.

✅Self Inspection: Managing self-inspection activities for all departments.

 📝 Interested candidates can share their resume at 📧 parichayindore@lupin.com