Quality Auditor Compliance Manager

  • Salary: 69.49 CHF ph contractor rate
  • REF Number: 00056551
  • Consultant: Adrien Guimard
  • Contact: 0041 (0) 800 106 106
  • Date Published: 30.01.2024
  • Closed Date: 22.02.2024
  • Sector:
  • Location: Basel,
  • Discipline:

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.

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 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

Apply:

For more information or to apply for this position, please contact Adrien on 0041 (0) 800 106 106 or email aguimard@ckqls.ch. Please could you send any correspondence in English. Please quote job reference 56551 in all correspondence.

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