CQV Lead

Vor 2 Tagen

Bern, Schweiz GXP CONSULTING Switzerland Vollzeit

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We are looking for CQV - Commissioning, Qualification and Validation Leads and Managers

GXP CONSULTING Switzerland is a Swiss company with a passionate team of Life Sciences professionals. Since 2014 we deliver outstanding industry expertise and support to our clients in the complete range of product life cycle.

ABOUT THE ROLE:

  • Lead the CQV team and oversee all commissioning, qualification, and validation activities within the pharmaceutical manufacturing facility.
  • Develop and manage project plans, ensuring alignment with project timelines and budgetary constraints.
  • Develop and implement CQV strategies that align with regulatory requirements and industry best practices.
  • Direct the execution of commissioning protocols, qualification activities, and validation studies for equipment, systems, and facilities.
  • Strong experience with Validation Master Plan, Commissioning Master Plan, project procedures and commissioning and qualification protocols (SAT/Commissioning, IQ and OQ).
  • Generation and execution of the system commissioning protocols, installation & operation qualification protocols, process qualification protocols.
  • Identify the appropriate Commissioning and Qualification strategy.
  • Schedule preparation and progress review.
  • Execute some commissioning and qualification activities (hands-on experience).

If you have done most of the above in the past, and you possess exceptional Leadership and People Management skills we have the job for you.

ABOUT YOU:

  • BSc/MSc Degree in Engineering, Bioengineering or any related field.
  • 7+ years of experience in commissioning and qualification activities for pharmaceutical facilities.
  • Experience in leading Commissioning and Qualification activities.
  • Previous experience as leader of C&Q team.
  • Strong knowledge and experience of Commissioning and Qualification.
  • Knowledge in qualification & validation approaches (especially ASTM E2500) is highly relevant.
  • Familiar with Kneat or equivalent.
  • Excellent analytical, problem-solving, and decision-making abilities.
  • Effective communication and interpersonal skills.
  • Fluency in English is required. German/French would be a clear plus.

ABOUT US:

  • We are a Human-sized company with great colleagues from a large diversity of cultural and professional backgrounds.
  • We do care about our people, communicate openly and value feedback.
  • We work as a team where every member is valued and appreciated.
  • We propose continuous learning and development opportunities via internal or external training and workshops.
  • We offer a competitive salary package in line with industry practice together with exceptional employment benefits.

At GXP Consulting Switzerland, everyone contributes to our joint success and grows individually

If you also share the same passion and values, we will be glad to hear from you

Seniority level

Mid-Senior level

Employment type

Full-time

Job function

Engineering, Project Management, and Production

Industries

Pharmaceutical Manufacturing, Biotechnology Research, and Operations Consulting

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