Our client, a leading pharmaceutical company based in Basel, are currently searching for a QA Auditor to join their team on a contract basis – contract duration TBC.  The ideal consultant will have at least 3 years of previous Lead Audit experience, as well as an excellent knowledge of GMP/GDP, international QA regulations and drug product development.

Responsibilities:

• Ensure GMP/GDP compliance at third party service providers
• Lead in establishing external QA Audit and internal self-inspection annual Plans
• 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 (not project specific)
• Write, review, and/or approve internal SOPs governing compliance related operations and other GMP/GDP and regulatory related documentation
• 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 the clients 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.

Required 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.
• Strong attention to detail, excellent organizational skills, ability to multitask effectively, and confidence in interacting with individuals at all levels, from junior to senior.
• Ability to pro-actively initiate and lead quality compliance activities.
• Confident and assertive in communication and decision-making.
• 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 GCP Audits is a plus point.