Job Title: QA Validation – Assistant Manager / Deputy Manager
Company: Amanta Healthcare Ltd.
Location: Plot No. 876, National Highway No. 8, Hariyala, Ta. Matar, Kheda – 387411, Gujarat, India.
About Amanta Healthcare Ltd.
Amanta Healthcare Ltd. is a leading name in the pharmaceutical industry, committed to manufacturing and delivering high-quality healthcare products. With a strong focus on compliance and innovation, we strive to maintain the highest standards in all our operations. We offer a dynamic work environment where talent is nurtured and contributions are valued. Join our dedicated team in Kheda, Gujarat, and be a part of our mission to excellence.
The Opportunity
We are seeking a highly skilled and experienced professional to fill the critical role of QA Validation – Assistant Manager / Deputy Manager. This position is central to ensuring the integrity and compliance of our sterile injectable and fill-finish manufacturing processes. The ideal candidate will possess a robust background in validation, sterility assurance, and cleanroom operations, ready to uphold and enhance our stringent quality standards. This role presents an excellent opportunity for a proactive individual to contribute significantly to our quality assurance framework and grow with a reputable organization.
Key Responsibilities:
- Process Validation: Oversee and manage comprehensive validation activities for critical sterilization equipment, including steam sterilizers (autoclaves), dry heat sterilizers, and depyrogenation tunnels.
- Aseptic & Fill-Finish: Develop and execute strategies for process simulation tests (media fills) and ensure all aseptic techniques strictly align with current regulatory annexes and guidelines.
- Equipment & Utilities Qualification: Lead the qualification efforts for essential manufacturing infrastructure, including HVAC systems, cleanrooms, pure steam generation, and Water for Injection (WFI) systems.
- Quality Management System (QMS): Actively participate in the review and approval of validation protocols, deviation reports, Corrective and Preventive Actions (CAPAs), and change controls.
- Compliance: Ensure all plant operations consistently adhere to cGMP (current Good Manufacturing Practices) and global regulatory guidelines. Serve as a Subject Matter Expert (SME) during internal and external regulatory audits.
Who We Are Looking For:
- Education: A Bachelor’s (B.Pharm) or Master’s (M.Pharm) degree.
- Experience: 8-10 years of dedicated experience within sterile injectable or fill-finish manufacturing environments.
- Specialized Focus: Demonstrated strong focus on sterility assurance and cleanroom operations.
- Technical Skills: Deep understanding and proven knowledge of microbiological testing, risk management principles, and relevant regulatory frameworks.
How to Apply:
Interested candidates are invited to submit their comprehensive resume/CV to careers@amanta.co.in. For further details or inquiries, please contact us at 9925021160.
