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Job type: Contract

Discipline: Validation

Location: Switzerland

Proclinical are recruiting for a C&Q Engineer to join a pharmaceutical organisation. This role is on a contract basis and is located in Bern.

Responsibilities:

You will plan and track implementation of commissioning & qualification actions/documentation versus project(s) timelines.
The ideal candidate will prepare, evaluate and approve technical and GMP linked documentation such as URS, FMEA, impact/risk assessment, master plans, qualification/validation documentation.
Ensure that Qualification/Validation Master plans are updated and formed for all ongoing projects.
Author/evaluate qualification/validation plans, which may involve DQ, IQ, OQ, PQ plans/protocols and final reports for new or modified GMP utilities, facilities, and process equipment.
Implement DQ, IQ, OQ, PQ, which involves protocol deviations, investigation, and corrective action activities for new or modified GMP utilities, facilities, and process equipment.
Arrange and implement FAT/SAT, commissioning activities for new GMP systems in collaboration with both internal and external partners.
Other duties may be assigned to this role.

Key Skills and Requirements:

Educated to a degree level in a technical or natural scientific field.
Demonstrable experience in a pharma organisation within a C&Q/CQV corresponding role.
Knowledge of qualification needs to cGMP guidelines.
Familiarity working with cross-department shareholders.
Knowledge of quality assurance principles.
Acquaintance working within project teams and various projects in parallel.
Prior involvement working with ISPE baseline guide vol 3, vol 4 and vol 5 would be beneficial.
Communication skills both verbally and in writing.
Able to think analytically with the ability to resolve issues.
Fluency in English with knowledge in German would be advantageous.
Able to manage own time efficiently.

If you are having difficulty in applying or if you have any questions, please contact Chloe Jack at +41 61 508 73 40.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

#Engineering

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Quality & Validation Specialist

Salary

Highly Competitive

Location:

Bern, Switzerland

Proclinical are recruiting for a Quality & Validation Specialist to join a biopharmaceutical organisation. This role is on a contract basis and is located in Bern.