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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.
Qualifications and Experience: 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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