QA Auditor Compliance Manager – 5712 ADA

 

Our client, an innovative and dynamic bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas, committed into delivering products on the market over the next 5 years, is looking for a QA Auditor Compliance Manager for 1 year contract starting in April with high possibility of extension based in Basel, 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.
  • 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 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.