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Quality Control Qualification and Validation Specialist

Michael Bailey Associates - UK Contracts

Posted on Mar 12, 2021 by Michael Bailey Associates - UK Contracts

Bern, Switzerland
15 Mar 2021
Annual Salary

Working for Medical Device client in Switzerland.

Job Title: Quality Control Qualification and Validation Specialist

Main Responsibilities 

Coordination of computerized system qualification and validation activities within the Quality Control department

Define the validation strategy

Perform and/or support the writing of specification documents (URS)

Review test protocols, plans and reports

Support test execution

Support and train team members in CSV methodology

Supporting the timely and effective completion of investigations, change controls and CAPA's

Experince & Qualifications
Degree in a LifeSciences/Biotechnology, Chemistry discipline or comparable work experience

Qualification & Validation of lab equipment in a Pharmaceutical envionment experience

Several years of experience in computerized system validation (CSV) in a GMP environment and good knowledge of related regulatory requirements in the life sciences industry (GAMP 5, 21 CFR part 11, ...)

Good understanding of analytical technologies,

Strong analytical thinking and problem-solving ability

Excellent communication and teamwork skills

Ability to simultaneously support multiple projects, duties and assignments and prioritize accordingly

 Excellent writing skills for scientifically sound technical documents, instructions, protocols and reports.

Self-dependent way of working and taking ownership of assigned task to plan and deliver according to agreed timelines.

Good verbal and written skills in English, German is a plus

Michael Bailey International is acting as an Employment Business in relation to this vacancy.

Reference: 1125445737

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