Lab Manager

Lab Manager

Requirements

• 5 years of experience in quality control within the pharmaceutical industry, including knowledge of Good Manufacturing Practices (GMP) and regulatory requirements.
• Ability to analyze complex data and laboratory results to make informed decisions and identify areas for improvement.
• Strong leadership abilities to manage and motivate a team, ensuring high performance and adherence to quality standards.
• Keen attention to detail to ensure accuracy in testing, reporting, and compliance with regulatory requirements.
• Proficiency in identifying issues and implementing effective solutions to resolve quality control problems.

Responsibilities

• Overseeing daily operations of the quality control laboratory to ensure adherence to the committed scheduled plans.
• Establish and prioritize lab quality control objectives.
• 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 usage of validated methods in his/her perimeter and executing any validation/transfer protocol as receiving unit.
• Contribute to develop and implement protocol (eg for validation, transfer, investigation…).
• Managing and training laboratory staff, ensuring they follow best practices and safety guidelines.
• Elaborate training programs.
• 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.
• Advise on testing schedules and priorities.
• Reviewing and approving laboratory test results and reports.
• Decide on the approval of test results.
• Maintaining laboratory equipment, by applying maintenance, qualification and calibration plans to ensure accuracy and reliability of lab activities.
• Advise about equipment maintenance schedules.
• Investigating on 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.
• Build remediation plans related to inspection readiness gaps, findings, deviations, …
• Ensuring that his/her lab/facilities, lab instruments, are kept in a quality and safety status to ensure that they can be used appropriately.

Preferred Qualifications

No preferred qualifications provided.