MAIN RESPONSIBILITIES:

• Overseeing daily operations of the quality control laboratory to ensure adherence to the committed scheduled plans
• Maintaining his/her laboratory in compliance with the GMPs and quality control processes defined according to internal and external quality requirements and regulations
• Ensuring the use of validated methods in his/her perimeter and executing any
• validation/transfer protocol as receiving unit
• Managing and training laboratory staff, ensuring they follow best practices and safety guidelines
• Ensuring his/her laboratory staff is qualified to perform the testing execution by maintaining the lab qualification matrix
• Conducting routine shopfloor of laboratory to identify improvement opportunities
• Ensuring accurate and timely testing of received samples according to his/her perimeter
• Reviewing and approving laboratory test results and reports
• Maintaining laboratory equipment by applying maintenance, qualification, and
• calibration plans to ensure accuracy and reliability of lab activities
• Ensuring the follow-up and progress of the investigations, change control, and CAPAs assigned to his/her perimeter, in a timely manner
• Investigating in a timely manner and resolving any quality control events, issues, or discrepancies from his/her perimeter. Implementing remediation actions from findings and CAPAs
• Providing support during regulatory inspections and audits by answering to requests related to his/her perimeter
• Ensuring that his/her lab/facilities, lab instruments are kept in a quality and safety status to ensure that they can be used appropriately

KEY ROLES:

• Establish and prioritize lab quality control objectives (D)
• Contribute to develop and implement protocol (e.g., for validation, transfer, investigation) (A)
• Elaborate training programs (D)
• Advise on testing schedules and priorities (A)
• Decide on the approval of test results (D)
• Advise about equipment maintenance schedules (A)
• Build remediation plans related to inspection readiness gaps, findings, deviations (A)

ADDITIONAL RESPONSIBILITIES:

• Ability to perform tasks in a Quality Control Laboratory environment. May be required to enter controlled environments following proper gowning protocols.