Technical QA Manager

vor 18 Stunden


Basel, Schweiz Manpower SA Vollzeit

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We are looking for a Technical QA Manager (m/f/d) (EW) - Metropolitan Area Basel

Tasks & 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

Must Haves:

* 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 haves:

* 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

Dissatisfied, underchallenged, or ready to discover something new?

What are you waiting for? Apply now, unlock your potential, and strive for greater satisfaction in your career.
I will support you with my expertise and guide you through the entire application process. I look forward to meeting you and hearing your story

MANPOWER AG - Together, we shape your future

Dragan Vasilic
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