Quality Auditor Compliance Manager
QLS are recruiting for a QA Auditor Compliance Manager to join an Innovative Pharmaceutical company based in Basel for 12 months.
Start Date: April 2024
Your main accountabilities include:
- 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.
- Interfacebetween 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 CAPAsrelated 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
- Monitor changes in quality regulations and initiate required activities to maintain compliance of the quality system
- 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 30%) may be required, including international travel.
- 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 tothe 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 verbaland 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
For more information or to apply for this position, please contact Adrien on 0041 (0) 800 106 106 or email firstname.lastname@example.org. Please could you send any correspondence in English. Please quote job reference 56551 in all correspondence.