QA Auditor
Vor 3 Tagen
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Responsibilities:- Ensure GMP/GDP compliance at third party service providers and within internal facilities.
- Lead in establishing external QA Audit and internal self-inspection annual Plan.
- Conduct GMP/GDP audit and self-inspections and coordinate with internal personnel and suppliers to schedule, execute and follow up with audit observations.
- Promptly report critical self-inspection findings to the Responsible Person and Management.
- Create, implement, maintain, and work with Vendors on establishing Quality Agreements where needed.
- Interface between quality/regulatory/compliance personnel and operations to identify applicable regulatory and compliance requirements and ensure accurate understanding of those requirements.
- Manage, review and approve change controls, deviations and CAPAs related to the internal pharmaceutical operations facilities (not project specific).
- Write, review, and/or approve internal SOPs governing compliance related operations and other GMP/GDP and regulatory related documentation.
- Provide Quality oversight over equipment qualification, calibration and validation.
- Support the preparation of Regulatory Authority Inspections.
- Monitor changes in quality regulations and initiate required activities to maintain compliance of the quality system.
- Support optimization quality system by working with cross-functional teams to obtain key performance indicators for the site and support the organization of Quality Management Review (QMR) meeting to communicate these metrics.
- Promote GxP and Quality mindset at all levels within the organization.
- Traveling (up to 30%) may be required, including international travel.
- Relevant Swiss working/residency permit and/or Swiss/EU-Citizenship required.
- University degree in Pharmacy, Chemistry or alternative technical/science university degree: master level minimum.
- Minimum 3 years’ experience in Auditing, 1 year as Lead Auditor.
- Knowledge and understanding of drug product development, manufacturing processes, as well as quality control, packaging and distribution aspects.
- Excellent knowledge of relevant GMP/GDP and international quality regulations e.g. ICH, ISO, WHO, PIC, FDA, EU GMP Guide (EudraLex Vol. 4), EU GDP and ability to interpret and implement quality standards.
- Ability to work on multiple projects with various disciplines and to manage complex projects and prioritize workloads according to the project importance.
- Attention to detail, organization, multi-tasking, and comfort interacting with people who might be junior or senior to the incumbent.
- Ability to pro-actively initiate and lead quality compliance activities.
- Self-confident, assertiveness and autonomy to deal with complex stakeholders/situations.
- Strong interpersonal and influencing skills.
- Fluent verbal and written communication skills in English and at least basic knowledge of an additional European language e.g. German or French.
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