QA Auditor Compliance Manager - CK Group - HELP
Overview:
We are seeking a highly skilled and experienced QA Auditor Compliance Manager, to ensure GMP compliance at third party service providers and within internal facilities. The successful candidate will 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.
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.
- Manage, review and approve change controls, deviations and CAPAs related to the internal pharmaceutical operations facilities.
- 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.
- Support optimization of 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 (20%-30%) may be required, including international travel.
Qualifications:
- 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.
- 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.
Day-to-day:
The QA Auditor Compliance Manager will be responsible for ensuring GMP compliance, conducting audits and self-inspections, managing change controls and deviations, supporting regulatory authority inspections, and promoting a quality mindset within the organization. The role will involve interfacing between various departments, managing complex projects, and traveling as required.
Benefits:
- Competitive contractor rate.
- Opportunity to work with a leading pharmaceutical company.
- Exposure to international travel and cross-functional collaboration.
- Contribution to the optimization of pharmaceutical quality systems.
If you are a mission-driven individual with a strong background in quality compliance and auditing, we encourage you to apply for this exciting opportunity.
Apply:
All applicants must be a Swiss citizen or EU citizen with a valid Swiss work permit. Please quote job reference in all correspondence.