Technical Quality Assurance Manager

Contract duration: 1 year

Extension: very likely

Responsibilities:

• QA supervision of qualification- and validation-activities for GMP-relevant equipment for Synthetic Molecule production and/ or Quality Control
• Responsible to ensure QA oversight and setting guardrails for the operation facilities regarding GMP and Quality standards
• Support of implementation of DI requirements
• Provide sound technical and quality assurance expertise for review and approval of quality related documents (e.g. Qualification plans and reports, change and deviation management, CAPAs, SOPs, Risk Analysis etc.)
• Performing deep root cause analyses as a facilitator or expert to address and investigate complex problems independently
• Responsible for driving and optimization activities and improvements within IMP Quality Operations Switzerland Partner with stakeholders and provide guidance to ensure successful delivery of the IMP goals
• Represent and support your area of responsibility at HA inspections and internal audits
• Support of end to end cGMP activities, in maintaining the Right to Operate at the Swiss Technical R&D sites and in ensuring quality and compliance of IMP products according to Health Authority requirements and Company Standards for IMP products

Requirements:

• Academical degree in Engineering, Chemistry, Life Science, Pharmacy or equivalent
• Fluent German and English are mandatory for this position
• Profound experience in the pharmaceutical industry
• Experience in equipment Qualification/Validation of synthetic molecules manufacturing and/or Quality Control
• Sound understanding on current DI (Data Integrity) requirements
• Profound knowledge of global quality and GMP requirements
• Successful performance in health authority inspections and internal GMP audits