C&Q Engineer (JJJP00007924)

  • Salary: 85 -100 CHF per hour all-in
  • REF Number: 00051926
  • Consultant: Adrien Guimard
  • Contact: 0041 (0) 800 106 106
  • Date Published: 04.11.2021
  • Sector: Pharmaceutical
  • Location: Bern, Bern Area
  • Discipline: Technical - CSV, Technical - Maintenance Engineer

QLS are recruiting for a C&Q Engineer to join an important project with a Global Biopharmaceutical Company at their site based in Bern on a contract basis until 30th of April 2022.

Main responsibilities:

  • 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
  • Qualification/Validation Master plans are up to date and established for all ongoing projects• Write/review Qualification/Validation plans, including but not limited to DQ, IQ, OQ, PQ plans/protocols and final reports for new or modified GMP utilities, facilities, and process equipment
  • Execution of DQ, IQ, OQ, PQ, including protocol deviations, investigation, and corrective action activities for new or modified GMP utilities, facilities, and process equipment
  • Plan and track execution of Commissioning & Qualification activities/documentation versus project(s) timeline
  • Prepare,review and approve technical and GMP related documentation (URS, FMEA, impact/risk assessment, Master plans, qualification/validation documentation)
  • Coordinate and execute FAT/SAT, commissioning activities for new GMP systems in collaboration with internal and external partners
  • Coordination and oversight of external suppliers

Candidate’s Requirements:

  • Bachelor/Master’s degree in technical or natural sciences
  • A minimum of 5 years of working experience within pharma company inC&Q/CQV equivalent position
  • Know-how of Qualification requirements according to cGMP regulations
  • Experience working with cross-department stakeholders
  • Know-how of quality assurance principles
  • Experience working in project teams and multiple projects in parallel
  • Experience working with ISPE baseline guide vol 3, vol 4 and vol 5 is a plus
  • Excellent communication skills
  • Analytical thinking and problem-solving ability
  • Business fluency in English
  • German language is a plus
  • Self time management

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 reference QLS 00051926 in all correspondence.

INDQLS

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