QA Auditor Compliance Manager - 6263 ADA
Location: Basel, Switzerland
Contract: 1 year with high possibility of extension
Company: Innovative and dynamic bio-pharmaceutical company headquartered in Switzerland
Main 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.
* Experience in Medical Devices is a plus.
Seniority Level: Not Applicable
Employment Type: Contract
Job Function: Quality Assurance
Industries: Pharmaceutical Manufacturing and Medical Equipment Manufacturing
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