Key Role: QC Lab Manager
The ideal candidate will oversee the daily operations of the IPC laboratory, ensuring compliance with regulatory requirements and company policies while driving continuous improvement initiatives.
* Lead the planning and execution of analytical method transfers for IPC testing, ensuring adherence to project timelines and objectives.
* Serve as the primary point of contact for all IPC technical transfer activities, liaising between internal analytical teams, manufacturing sites, and external partners.
* Coordinate the development and validation of IPC analytical methods, including protocol design, execution, and documentation.
* Conduct risk assessments and troubleshooting activities to address IPC technical challenges and ensure the successful implementation of analytical methods.
* Generate and review technical documents, including IPC transfer protocols, reports, and standard operating procedures (SOPs), to support IPC method transfer activities.
Requirements:
* Bachelor's degree in Biological Sciences, Chemistry or other biotechnical science or equivalent experience in a regulated industry.
* Minimum 10 years of laboratory experience in a GMP laboratory environment.
* 5 years of analytical instrument validation/qualification experience preferable.
* Proven leadership of laboratory staff and experience in a GMP laboratory setting.
* Proven ability to work in a matrixed organisation.
* In-depth understanding of current regulatory requirements for IPC or QC, including analytical testing, data integrity, and cGMP laboratory equipment validation.