Senior Quality Assurance Specialist

Location: Stein

Contract duration: 6 months

Workload: 60%

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.

Requirements:

• 7+ 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.).
• Project management certification would be considered as advantage (Green/Black Belt etc.).