Lupin Limited, a leading transnational pharmaceutical company and one of India’s largest manufacturers of bulk drugs and formulations, invites highly motivated and experienced professionals to join our state-of-the-art, USFDA-approved facilities in Pithampur, Indore, Madhya Pradesh. We are an innovation-driven organization committed to providing high-quality pharmaceutical products globally. This is your chance to contribute to a company at the forefront of the pharmaceutical industry.
Current Job Openings:
We currently have several exciting openings for skilled professionals. Below are the detailed descriptions for each position:
1. Officer – Packaging Development
About the Role: As an Officer in Packaging Development, you will play a crucial role in ensuring the quality and integrity of our pharmaceutical products. Your responsibilities will span the entire packaging lifecycle, from initial development to final commercialization. This position demands a strong understanding of packaging technologies and regulatory guidelines.
Responsibilities:
- Develop primary, secondary, and tertiary packaging materials for oral solid dosage forms, including oral contraceptives.
- Possess in-depth knowledge of oral solid and oral contraceptive dosage form packaging processes and technologies.
- Demonstrate expertise in the development, scale-up, and execution of exhibit batches.
- Review commercial, exhibit, and intended filing documents (e.g., BPR, specifications, equivalency reports, transpiration protocols).
- Maintain awareness of regulatory guidance from the USA, EU, and other international markets.
- Excellent communication and writing skills, and a thorough understanding of Good Documentation Practices (GDP).
- Proficiency in SAP handling and quality system software.
Qualifications:
- Bachelor of Pharmacy (B.Pharma) or other relevant degree in packaging development.
- 2-7 years of relevant experience in the pharmaceutical industry.
Compensation: Up to INR 7.50 LPA
2. Officer/Executive – Quality Control (Nasal Exposure)
About the Role: The Quality Control Officer/Executive will be responsible for ensuring the quality and compliance of nasal and derma formulations. This role requires a strong analytical background and a deep understanding of pharmaceutical quality systems.
Responsibilities:
- Conduct analysis of nasal and derma formulations, including in-process, finished product, and stability samples.
- Perform routine QC analyses using HPLC, GC, and other relevant instrumentation.
- Demonstrate expertise in pharmaceutical quality systems (QAMS).
- Thorough understanding of data integrity, GMP, laboratory instrument software, and 21 CFR guidelines.
- Work as a QC analyst, ensuring accurate and timely testing.
Qualifications:
- Bachelor of Pharmacy (B.Pharma) or Master of Science (M.Sc.) in a relevant field.
- 2-10 years of experience in pharmaceutical quality control.
Compensation: Up to INR 9.50 LPA
3. Officer – QA Doc Cell (API Exposure)
About the Role: The QA Doc Cell Officer will be responsible for managing and maintaining the quality assurance documentation system. This crucial role ensures compliance with regulatory requirements and GMP standards. This requires meticulous attention to detail and organizational skills.
Responsibilities:
- Manage and maintain the organization of documents and records within the document cell.
- Track documents for effectiveness, submission, retrieval, discontinuation, obsolescence, and destruction, following established SOPs.
- Ensure document retention complies with regulatory requirements.
- Monitor document cell activities to ensure compliance with SOPs and GMP standards.
- Prepare and review specifications, standard test procedures, and test data sheets for raw materials, packaging materials, in-process materials, intermediates, APIs, and finished products.
- Prepare and review quality assurance department SOPs.
- Initiate and review change controls, deviations, and other quality system (QAMS) documents.
- Track QAMS events for timely closure.
- Issue, retrieve, and destroy documents (SOPs, specifications, standard test procedures, logbooks, etc.).
- Update documents in Omni Docs as per SOP.
- Manage Master BMR/BPR linking/delinking and printing from SAP.
- Prepare master plans (Master Inspection Characteristic Reports) in SAP.
- Prepare and review e-TDS, SAP annexures, and related activities (merging, uploading, linking/delinking, and printing in SAP).
- Number all QAMS documents and log them into respective records/systems.
- Perform e-DMS activities, including QA authorization.
Qualifications:
- Bachelor of Science (B.Sc.) and Bachelor of Pharmacy (B.Pharma).
- 2-6 years of experience in a pharmaceutical QA document control role.
Compensation: Up to INR 5.50 LPA
4. Executive – QA (API Exposure)
About the Role: This senior QA role requires a high level of expertise in pharmaceutical quality assurance, particularly related to APIs. The successful candidate will be responsible for ensuring the quality and compliance of our API manufacturing processes.
Responsibilities:
- Prepare and review QA SOPs and review SOPs from other departments.
- Perform batch release of API materials and review associated documentation.
- Prepare and review quality risk assessments, site master files, hold time study protocols/reports, other study protocols/reports, specifications, stability protocols, and stability report data.
- Review validation master plans.
- Review analytical method transfer protocols/reports and method validation documents for APIs.
- Investigate out-of-specification results (OOS), out-of-trend (OOT) results, deviations, product failures, and market complaints.
- Review quality system documents (deviations, change controls, CAPAs, OOS, OOT, reprocessing, rework, market complaints, market returns).
- Review qualification protocols/reports for products, equipment, and facilities.
- Review annual product quality reviews.
- Review master documents (BPRs, test and calibration data sheets, test procedures, microbiological test procedures).
- Collect, review, and submit documents to the RA department for dossier preparation/regulatory submission.
Qualifications:
- Master of Science (M.Sc.) in Chemistry.
- 8-10 years of experience in pharmaceutical quality assurance, with a focus on APIs.
Compensation: Up to INR 8.50 LPA
How to Apply:
Interested candidates are encouraged to submit their resumes to parichayindore@lupin.com.
