Quality System Specialist - Cleanroom Operations (Medha, Ahmedabad)
Accumax Lab Devices Pvt. Ltd. is seeking a passionate Quality System Specialist to join our growing team!
Do you have a proven track record of maintaining a pristine cleanroom environment and ensuring compliance with industry standards Are you a detail-oriented individual with a strong understanding of Good Manufacturing Practices (GMP) If so, we want to hear from you!
In this critical role, you will play a vital part in safeguarding the quality and functionality of our life science and biopharmaceutical consumables. You'll be responsible for overseeing all aspects of cleanroom operations, including:
- Establishing and maintaining cleaning procedures: Develop and implement cleaning protocols for all production areas, including cleanrooms and airlocks.
- Cleanroom validation: Manage the validation process for new cleanrooms, ensuring they meet stringent cleanliness standards.
- Gowning procedures: Oversee gowning practices for personnel entering the cleanroom, ensuring appropriate selection, use, and maintenance of cleanroom garments.
- Operator training: Deliver comprehensive training to operators on proper cleanroom etiquette, gowning procedures, and cleaning protocols.
- Continuous monitoring: Implement and manage a cleanroom monitoring control plan to ensure consistent adherence to cleanliness standards.
- Compliance and Standards: Uphold compliance with ISO 14644 standards for cleanroom environments.
- Contamination control: Lead containment and investigation efforts in case of particle excursions within the cleanroom.
- Corrective actions: Initiate corrective and preventative actions, including fumigation, plant shutdown, and requalification processes as needed.
- Quality System Support: Collaborate in the development and implementation of cGMP-compliant systems, including SOPs, forms, and work instructions.
- Internal/External Audits: Assist with internal quality audits and prepare audit reports. Participate in external GMP audits of vendors.
To be successful in this role, you will possess the following qualifications:
- 5+ years of experience working in cleanroom production environments.
- Demonstrated success in enforcing cleanroom compliance and training operators.
- A strong understanding of ISO 14644 standards and related cleanroom protocols.
- Excellent communication and training skills.
- Proactive problem-solving abilities.
- A meticulous and detail-oriented work style.
- Experience working in a multicultural environment (a plus).
- Familiarity with US, EMA, and ICH quality guidelines (a plus).
Ready to join a dynamic team and make a real difference in the biopharmaceutical industry We offer a competitive compensation package and a stimulating work environment. Submit your resume to [Confidential Information] or [HIDDEN TEXT] today!
