- Ensure compliance with regulatory requirements, company policies, and industry standards for quality control and compliance.
- Develop, implement, and maintain analytical methods for stability studies to ensure product quality.
- Conduct audits and inspections to identify areas of improvement in manufacturing processes.
- Collaborate with cross-functional teams to resolve issues related to product quality.
Job Requirements :
- 15-25 years of experience in pharmaceutical or life sciences industry as a Quality and Compliance Manager or similar role.
- Robust knowledge of analytical method validation, stability studies, and regulatory requirements (e.g., FDA).
- Proven track record of implementing effective quality management systems (QMS) in accordance with ISO 13485:2016 standard.