Technical QA Manager
Auf einen Blick
- Veröffentlicht:30 Januar 2025
- Pensum:100%
- Vertragsart:Temporär
- Arbeitsort:4051 / Basel
INTRODUCTION
ASSIGNMENT DESCRIPTION
As a preferred supplier for Roche in Basel, we are looking for an individual
Technical QA Manager (m/w/d)This is a full-time position (100%) with a 1-year duration and the possibility of extension. The ideal start date is as soon as possible and the latest 01.04.2025. Home Office: Onsite required, home office upon discussion.
ASSIGNMENT DESCRIPTION
- 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 (*****)
Nice to Have:
- Great communicator to stakeholders and in the team (*****)
- "Can-Do" attitude and self-confident to take over new responsibilities and tasks
- Ability to speak up, listening to other opinions and able to rethink the own way to ensure a highest level of success
- Knowledge of Pharmaceutical Development and about the special needs and road blocks regarding GMP-compliant production
Interested? You can find more information here:
