QA Auditor Compliance Manager
vor 23 Stunden
**_The Life Science Career Network_**
**QA Auditor Compliance Manager**
Our client is a pioneer in Drug Discovery and Development and one of the frontrunners in Personalised Healthcare. As the world's largest R&D spender in the pharmaceutical and diagnostics domain, they work in a vast number of drug discovery & therapeutic areas and are highly recognized internationally.
We are currently looking for a QA Auditor Compliance Manager for a 9-month contract based in Basel, Switzerland.
**Main Responsibilities**:
- Ensure GMP compliance at third party service providers and within internal facilities
- Lead or assist 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
- Provides Quality oversight over equipment qualification, calibration and validation
- Support the preparation of Regulatory Authority Inspections
- Support optimization of company's pharmaceutical 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 50%) may be required, including international travel
**Qualifications and Experience**:
- University degree in Pharmacy, Chemistry or alternative technical/science university degree: master level minimum
- Minimum 3 years experience in Auditing, 1 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
- 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
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