Senior QA Expert for QC Specialist

Main Responsibilities:

·Collaborate closely with cross-functional teams to work on growth projects as per site quality objectives and strategic goals. Ensure that project timelines and deliverables under the responsibility of QA/QC are fulfilled.

·Provides guidance and quality oversight for QC

·Support growth projects and act as primary point of contact in QA for implementation of gLIMS (laboratory execution system)

·Represents the QA support and guidance to the Quality Control (QC) department and ensures that GMP requirements are met and SOPs are followed.

·Review and Approval of GMP relevant documents from quality control, including SOPs with focus on implementation of gLIMS.

·Supervise and execute GMP compliance activities like changes (CRs), document management, non-conformities (DRs)

·Write or revise SOPs in the area of expertise and be the owner of these documents.

·Support QA for QC raw data review, as deemed required

·Meet internal and external guidelines regarding quality and safety (quality manuals, regulatory GMP guidelines, health authority guidance, SOPs, HSE, etc.)

·Management and reporting of KPIs

·Perform/support inspections and audits as required.

·Performs other duties as assigned

Qualifications and Experience:

·Relevant working/residency permit or Swiss/EU-Citizenship required

·8 years + experience in projects in implementation of laboratory execution systems, within a quality-focused environment.

·Strong background in cGMP regulations, including US, European and Japanese Pharmacopoeia.

·Very good knowledge in laboratories/laboratory equipment/software qualification/validation.

·Experience in interaction with health authorities (FDA, Swissmedic, etc.).

·Structured, focused and well-organized working attitude.

·Open-minded for new ideas and suggestions, agile, highly motivated and dynamic drive.

·Pragmatic and solution-orientated mindset.

·Fluent in English, German language is nice to have

·Project management certification would be considered as advantage (Green/Black Belt etc