Technical Quality Assurance Manager ROCGJP00028872

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
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