- 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
- Academical degree in Engineering, Chemistry, Life Science, Pharmacy or equivalent
- 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
- Strong team-player with a high level of self-motivation and the ability to effectively influence others across all levels of the organization
- Successful performance in health authority inspections and internal GMP audits
- Fluent German and English (spoken/written) is a must for this position
- Knowledge of Pharmaceutical Development and about the special needs and road blocks regarding GMP-compliant production advantageous
- Fascinating, innovative environment in an international atmosphere
- Unlimited project contract
Ihr Kontakt
Referenznummer
800072/1
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Telefon:+41 44 225 50 00
E-Mail: positionen@hays.ch
Anstellungsart
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