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Quality Control Manager
2 months ago
About the Role
The Senior Analyst, Quality Control position at Sun Pharma is a critical role that requires a strong leader to maintain a site-wide quality program that meets Taro, Canadian, and FDA cGMP requirements.
Key Responsibilities
- Lead a team of analysts to conduct GMP laboratory testing, providing coaching, subject-matter-expertise, and technical mentorship.
- Develop and implement new laboratory requirements, business operations, and technologies to enhance the analyst team's capabilities.
- Provide troubleshooting of test method and equipment issues, and lead internal lab investigations, including trending and preventative actions.
- Train analysts in analytical methods and onboard new employees, ensuring they are equipped to perform their duties effectively.
- Conduct in-process, bulk, finished goods, stability, validation/verification, and investigation sample testing, as well as method transfer activities.
- Collaborate with the Quality Control Supervisor to determine priorities, coordinate workload, and communicate with the team on group priorities.
- Support internal and regulatory inspections, and recommend, design, and deliver training to ensure technical capability and compliance with SOPs, Canadian, and FDA cGMP, and HS&E requirements.
- Identify and implement key process improvements to enhance systems, gain site efficiencies, and elevate GMP requirements.
Development Focus
- Develop and validate methods within the QC lab for HPLC and other instrumental techniques, with the goal of updating and improving existing methods.
- Develop and validate cleaning validation methods as required.
- Conduct IV drug release testing for product comparison.
- Perform process validation and cleaning validation testing.
- Lead method transfer activities, new product introductions, and product, method, and raw material troubleshooting.
- Lead projects in the area of focus related to process improvement.
- Collaborate with the Quality Control Supervisor to determine priorities, coordinate workload, and communicate with the team on group priorities.
- Act as a subject-matter-expert and provide technical assistance, coaching, and guidance to the team.
