C&Q Engineer in Bern

The position will report to the C&Q Manger and is in charge of Commissioning & Qualification (C&Q) activities for Technical Services department in order to ensure that:

(re-) qualification of production/QC equipment including thermal mapping studies are performed according to global and local company policies and procedures as well as legal requirements and requirements set by regulatory authorities.

Commissioning & Qualification Master plans are up to date and established for all ongoing projects.

Write/review Commissioning & Qualification plans and reports.

Execution of RQ, IQ, OQ, PQ, including protocol deviations, investigation, and corrective action activities

Plan and track execution of Commissioning & Qualification activities/documentation versus project(s) timelines

Prepare, review and approve technical and GMP related documentation (URS, FMEA, impact/risk assessment, Master plans, qualification/validation documentation)

Coordinate and execute commissioning & qualification activities in collaboration with internal and external partners

Coordination and oversight of external suppliers

Qualifications and Skills:

Bachelor/Master’s degree in technical or natural sciences

Working experience within pharma/Medical Devices companies

Practical experience in a C&Q role is a must

Know-how of Qualification requirements according to cGMP regulations

Know-how of thermal mapping studies

Know-how of quality assurance principles

Excellent communication skills

Analytical thinking and problem-solving ability

Business fluency in English

German language is a plus

Self time management

For our client, an international company based in Bern, we are looking for a C&Q Engineer.

General Information:

Start date: ASAP, latest in January 2025

Contract duration: 1 year with possibility of extension

Workplace: Bern

Workload: 100%

Home office: possible up to 2 days per week

Tasks and Responsibilities:

The position will report to the C&Q Manger and is in charge of Commissioning & Qualification (C&Q) activities for Technical Services department in order to ensure that:

(re-) qualification of production/QC equipment including thermal mapping studies are performed according to global and local company policies and procedures as well as legal requirements and requirements set by regulatory authorities.

Commissioning & Qualification Master plans are up to date and established for all ongoing projects.

Write/review Commissioning & Qualification plans and reports.

Execution of RQ, IQ, OQ, PQ, including protocol deviations, investigation, and corrective action activities

Plan and track execution of Commissioning & Qualification activities/documentation versus project(s) timelines

Prepare, review and approve technical and GMP related documentation (URS, FMEA, impact/risk assessment, Master plans, qualification/validation documentation)

Coordinate and execute commissioning & qualification activities in collaboration with internal and external partners

Coordination and oversight of external suppliers

Qualifications and Skills:

Bachelor/Master’s degree in technical or natural sciences

Working experience within pharma/Medical Devices companies

Practical experience in a C&Q role is a must

Know-how of Qualification requirements according to cGMP regulations

Know-how of thermal mapping studies

Know-how of quality assurance principles

Excellent communication skills

Analytical thinking and problem-solving ability

Business fluency in English

German language is a plus

Self time management

kontaktiere uns.

wir sind da um deine Fragen zu beantworten.

LN

Lucie Nasshan

+41 58 201 55 50
Basel Professionals Life Sciences

der Bewerbungsprozess.

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mit randstad bewerben.

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background check.

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Kontakt

Lucie Nasshan

Referenznummer

22911

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Job Details

For our client, an international company based in Bern, we are looking for a C&Q Engineer.

General Information:

Start date: ASAP, latest in January 2025

Contract duration: 1 year with possibility of extension

Workplace: Bern

Workload: 100%

Home office: possible up to 2 days per week

Tasks and Responsibilities:

Firma: Randstad Schweiz AG

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