Website:
inotek.co.in
Job details:
Company Description
Inotek Technologies Pvt. Ltd. is a Design and Engineering consulting firm specializing in serving the pharmaceutical and life sciences industry. The company focuses on regulatory-driven facility design and operates in high-complexity domains including Cell & Gene Therapy, biosimilars, oncology, and advanced biologics. Inotek leverages global regulatory frameworks, such as USFDA, EU-GMP, WHO, and PIC/S, to shape inspection-ready facilities for predictable approvals and controlled execution. With strong expertise in conceptual design, detailed engineering, validation strategies, and quality systems, Inotek delivers solutions that blend technical depth with regulatory insight. Based in Noida, Inotek operates at the intersection of engineering and regulatory science, ensuring compliance-led success in every project.
🔹 Key Responsibilities:
✔ Preparation and review of VMP, CQMP, SOPs, protocols, reports, and QMS documents
✔ Preparation, review, and implementation of Standard Operating Procedures (SOPs) related to equipment, utilities, validation, quality systems, and operational activities
✔ Development of URS, Risk Assessments, RTM, DQ, IQ, OQ, PQ documents
✔ System classification as per ISPE Guidelines
✔ FAT/SAT coordination and qualification execution
✔ QMS activities including Deviation, Change Control, CAPA, and documentation management
✔ Analytical instrument qualification knowledge
✔ Compliance with FDA, EU GMP, WHO GMP, ISPE, and GAMP guidelines
✔ Execution of CQV activities for pharmaceutical equipment, utilities, HVAC, cleanrooms, and process systems
✔ Coordination with clients, vendors, and project teams for successful project execution
🔹 Candidate Profile:
✅ 5–8 years of relevant pharmaceutical CQV/QA experience
✅ Strong knowledge of GMP documentation, SOP preparation, and QMS systems
✅ Experience in commissioning & qualification of pharma equipment and utilities
✅ Good communication and project coordination skills
✅ Exposure to Injectable facility projects will be an added advantage
✅ Experience of working with Pharmaceutical Design Consultant will be an added advantage
If you are passionate about pharmaceutical compliance and validation excellence, we would love to connect with you.
- 📩 Interested candidates may share their CV at: hr@inotek.co.in
- Location: Noida
- No. of Post: 02
Click on Apply to know more.