Essential Duties & Responsibilities: |
• Responsible for building a new Quality Control team and establishing a GLP compliant Quality Control lab for a commercial manufacturing site. This includes analytical, microbial, technical services, stability, and sample management groups for sterile pharmaceutical products |
• Provide direction for analytical, microbial, technical services and sample management groups to ensure timely testing |
• Ensure Laboratory Equipment and Utility Qualifications, Appropriate qualification/validation of analytical methods and transfer and validation of methods between manufacturing sites |
• Ensures that QC Systems and practices are developed and implemented in accordance with the requirements of cGMP |
• Establishes and publishes Key Performance Indicators to track cGMP compliance for the Quality Control function |
• Works with senior stakeholders, develops plans and strategic direction for the team |
• Collaborate with FDA as the need arises representing the firm to authorities and regulatory inspectorates in matters relating to GMP |
• Supports standardization and harmonization of Standard Operating Procedures |
• Participate in inspections and audits of the laboratories |
• Direction of QC functional groups to ensure timely testing |
• Oversight of laboratory training programs |
• Responsible for conducting laboratory investigations, OOS, OOT |
• Generation of CoAs for product release |
• Draft analytical and stability sections of regulatory submissions |
• Monitor and trend data while assembling reports on product release test monitoring of company cGMP facility |
• Frequently update stakeholders on trends |
• Implement corrective action plans |
• Tracking of data from external contract laboratories to complete lot disposition |
• Establish user requirements for purchase, qualification of QC analytical equipment |
• Work with internal and external resources to maintain equipment in an efficient state |
• Develop, revise and review SOPs, qualification/validation protocols and reports |
• Monitor the GMP systems currently in place to ensure compliance with documented policies |