C&Q Engineer

  • Salary: 85-105 CHF per hour (all incl)
  • REF Number: 00051216
  • Consultant: Adrien Guimard
  • Contact: 0041 (0) 800 106 106
  • Date Published: 23.07.2021
  • Sector: Bern Area
  • Location: Bern, Experienced
  • Discipline: Technical - Validation, Technical - Maintenance Engineer

CK QLS are recruiting for a C&Q Engineer to join an important project with a global Pharmaceutical Company at their site based in Bern on a contract basis until the end of the year.

C&Q Engineer Role: The main purpose of the role will be to:

  • Ensure that Qualification/Validation phases are performed according to global and local company policies and procedures as well as legal requirements and requirements set by regulatory authorities.
  • Ensure that Qualification/Validation Master plansare up to date and established for all ongoing projects in QC.
  • Plan, coordinate and execute all phases for qualification of GMP manufacturing systems including but not limited to, Qualification/Validation plans, FMEA, DQ, IQ, OQ, PQ.
  • Prepare, review and approve technical and GMP related documentation (URS, impact/risk assessment, Master plans, qualification/validation documentation).
  • Coordinate and execute FAT/SAT, commissioning activities for new manufacturing systems in collaborationwith internal and external partners.
  • Coordination and oversight of external suppliers.
  • Operational handling of Change Controls, CAPAs and Non-Conformances related to qualification topics.
  • You will be especially dedicated to activities related to thermal mapping and autoclave.

Your Background: In order to be considered for this role, you will be required to have the following qualifications, skills and experience:

  • Bachelor/Master degree in Technical or Natural Sciences.
  • A minimum of 3 years of working experience within pharma company in C&Q equivalent position.
  • Know-how of commissioning and qualification requirements according to (c)GMP regulations.
  • Know-how of quality assurance principles and experience working with cross-department stakeholders.
  • Excellent communication skills.
  • Analytical thinking and problem-solving ability.
  • Business fluency in English.
  • German language is a plus.
  • Self time management.

Apply: For more information or to applyfor this C&Q Engineer position, please contact Adrien on 0041 (0) 800 106 106 or email aguimard@ckqls.ch, quoting job ref 51216.

Please could you send any correspondence in English.

It is essential that applicants hold entitlement to work in Switzerland.

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