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C&Q Engineer

Switzerland   •  Contract/Temporary, Full time


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 in C&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


You must have the right to work in Switzerland.

  • Agency: CK Group
  • Contact: Adrien Guimard
  • Phone: 01438 723 500
  • Reference: 51926
  • Updated: 18th October 2021
  • Expires: 15th November 2021

CK Group

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