Job Opportunity: QC GLP Officer – Shape the Future of Injectable Pharmaceuticals!
Summary:
Indus Pharma Private Limited, a rapidly expanding injectable manufacturing company, is seeking a highly motivated and detail-oriented QC GLP Officer to join our Quality Control team. Located in our state-of-the-art facility in Ghiloth, Neemrana, Rajasthan, you will play a crucial role in ensuring adherence to the highest standards of Good Laboratory Practices (GLP), Current Good Manufacturing Practices (cGMP), and international regulatory guidelines (USFDA, WHO, MHRA). If you have a strong foundation in pharmaceutical quality control, a passion for data integrity, and a desire to contribute to a dynamic and growing organization, we encourage you to apply.
About Indus Pharma Private Limited:
Indus Pharma Private Limited is committed to excellence in the development and manufacturing of high-quality injectable pharmaceuticals. Our modern facility is equipped with cutting-edge technology and operates under stringent quality control systems. We are dedicated to fostering a culture of continuous improvement, innovation, and employee development.
Job Title: QC GLP Officer
Location: Plot No. A-181, RIICO Industrial Area, Ghiloth, Neemrana, Rajasthan
Experience: 1-4 Years (Candidates with 3-7 years of relevant experience are also encouraged to apply)
Industry: Pharmaceutical – Injectables
Salary: ₹4,00,000 – ₹7,00,000 per annum (Commensurate with experience and skills)
Responsibilities:
As a QC GLP Officer, you will be responsible for:
- GLP & cGMP Compliance: Monitoring all QC laboratory activities to guarantee strict adherence to GLP, cGMP, and relevant regulatory standards.
- Data Integrity: Performing routine checks for data integrity, traceability, instrument cleanliness, and adherence to established analyst practices. Ensuring complete compliance with ALCOA+ principles in all documentation.
- Documentation Review: Thoroughly reviewing laboratory logbooks, instrument usage logs, calibration records, raw data, worksheets, and analytical reports to identify and address any inconsistencies or deviations.
- SOP Management: Assisting in the preparation, revision, and implementation of QC and GLP-related Standard Operating Procedures (SOPs).
- Audits & Inspections: Actively participating in internal audits and providing support during external regulatory inspections conducted by agencies such as USFDA, WHO, and MHRA.
- Deviation Management: Contributing to deviation investigations, Out-of-Specification (OOS) and Out-of-Trend (OOT) investigations, and the implementation of Corrective and Preventive Actions (CAPA).
- Self-Inspection & Validation: Performing self-inspections of the QC laboratory and supporting the Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) of analytical instruments.
- Instrument Maintenance: Maintaining calibration and preventive maintenance schedules for critical analytical instruments, including HPLC, GC, UV, IR, and Dissolution Testers.
- Training & Development: Providing GLP training to analysts and new team members to ensure a high level of understanding and compliance.
- Sample & Reagent Management: Ensuring the proper handling, labeling, storage, and environmental monitoring of samples and reagents within the QC laboratory.
Qualifications & Skills:
- Education: B.Sc. / M.Sc. in Chemistry / Biotechnology / Microbiology or a related scientific discipline.
- Experience: 1-4 years of experience in Quality Control within the pharmaceutical industry, with a preference for candidates with experience in injectable manufacturing.
- Knowledge: Comprehensive understanding of GLP, GMP, GDP, ALCOA+, OOS/OOT handling, and international regulatory guidelines (WHO, USFDA, MHRA).
- Instrumentation: Hands-on experience with analytical instruments, including HPLC, GC, UV, IR, and Dissolution Testers.
- Documentation: Excellent documentation skills and experience in preparing and reviewing quality control documentation.
- Auditing: Experience in facing audits and inspections from regulatory agencies.
- Soft Skills: Strong analytical and problem-solving skills, excellent communication skills, and the ability to work effectively in a fast-paced, team-oriented environment.
Why Join Indus Pharma Private Limited?
- State-of-the-Art Facility: Work in a modern injectable manufacturing facility that adheres to global standards.
- Career Growth: Benefit from excellent growth opportunities within the Quality Control and Regulatory Affairs departments.
- Competitive Compensation: Receive a competitive salary and benefits package.
- Global Exposure: Gain valuable experience in navigating USFDA, WHO, and MHRA audits.
- Supportive Culture: Thrive in a supportive work culture that emphasizes continuous training and development.
How to Apply:
If you are a motivated and qualified candidate who is eager to contribute to a dynamic and growing pharmaceutical company, we encourage you to apply. Please submit your updated resume to [email protected] with the subject line: “Application for QC GLP Officer – Neemrana – [Your Name]”.
We look forward to hearing from you!