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Position overview

The QC Lab Manager IPC will work on establishing the In-Process Control (IPC) laboratory in the InsuLINK project at IFF for the active pharmaceutical ingredient (API) production of insulins. This role will span the planning phase, qualification, final approval, and transition to routine operations.You will onboard, manage and train laboratory staff, ensuring they follow best practices and safety guidelines whilst ensuring staff qualification to perform the testing execution. You will have disciplinary and technical leadership of an in-process control laboratory with more than 50 employees (current target HC). Together with other Q-functions, you will develop procedures and documents to commission equipment and analytical methods in accordance with applicable GMP requirements, internal quality standards, and regulatory specifications. Furthermore, you will support the commissioning of IFB.

Main responsibilities:

• Planning and Commissioning of a new In-Process-Control (IPC) Laboratory within the InsuLINK Project
• Provision of analytical expertise for projects, troubleshooting and investigations related to analytical methods and laboratory technologies, particularly in-process controls in the insulin manufacturing process
• Review and approval of protocols and reports related to analytical validation/transfer activities, precise standard operating procedures and qualification measures; Support during the establishment of IFF and providing assistance for IFB
• Oversee the daily operations of the in-process control laboratory to ensure adherence to the committed scheduled plans
• Laboratory management including ensuring cGMP and HSE compliance: Ensuring compliant execution and documentation of all laboratory processes according to current regulations for pharmaceutical manufacturing
• Concludes on the conformance of analytical test results with regards to specification
• Ensuring GMP-compliant, timely execution and documentation of quality testing of pharmaceutical products
• Documentation of all required raw data, calculations and information to comply with cGMP and data integrity requirements
• Timely information to QC Manager about quality or HSE-relevant events (deviations, OOx, etc.) to ensure appropriate investigation and impact assessment
• Ensuring proper documentation of deviations, non-conformities and corrective actions
• Active participation in all investigations to ensure proper conduct of investigations and impact assessments.
• Establishment and execution of audit trail reviews for computerized systems
• Planning, coordination and evaluation of improvement initiatives and compliance projects. Ability to identify problems and implement effective solutions to resolve quality control issues
• Department representation in internal and external quality and HSE audits: active participation in inspections as SME
• Trouble shooting and root cause analysis
• Resource and capacity planning

About you

• Education/Experience: Scientific degree in natural sciences, preferably with a focus on analytics; minimum 5 years of professional experience and management experience including knowledge of Good Manufacturing Practices (GMP) and regulatory requirements; Experience in qualification/validation activities in the pharmaceutical or biotechnological industry 
• Soft and technical skills: Strong leadership skills to guide and motivate the team to ensure high performance and adherence to quality standards within the project; Experience and knowledge  of regulatory requirements and guidelines (e.g. FDA, EMA, 21CFR) related to validation and qualification, analytical methods and quality control; HPLC knowledge with a focus on protein analytics; very good technical understanding in handling laboratory equipment as well as equipment qualification and method validation; Excellent communication skills for effective collaboration with cross-functional teams to ensure smooth execution of qualification/validation activities; Ability to manage multiple projects, including planning, execution and monitoring, to ensure timely completion
• Languages: proficiency in German and English

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