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Validation (Quality Control Qualification and Validation)

Location: Bern
Sector: Computer System Validation & Quality Assurance
Job Type: contract
Salary: Negotiable
Reference: BBBH594606

Quality Control Qualification and Validation Specialist

Experis is the global leader in professional resourcing and project-based workforce solutions.

On behalf of our client, a global Pharmaceutical company in Bern, we are looking for a Quality Control Qualificaiton and Validation Specialist.

General Informantion:

Job Type: Contract

Job duration: 6 Months with possible extension

Job location: Bern

Start date: 10.06.2024 (ASAP)

End date: 31.12.2024 (extendable)

Main Responsibilities

● Archival of QC Analytical equipment's electronic data according to Pharma regulations, site procedures and IT policies

● Definition of the validation strategy and compliance activities required for archival of electronic data

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

● 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

Who we are looking for

● Degree in a LifeSciences/ Biotechnology, Chemistry discipline or comparable work 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, ...)

● Strong understanding of the process of electronic data archival within a GMP environment

● Good understanding of analytical technologies

● Good IT knowledge

● 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

Interested in this opportunity? Kindly send us your CV today through the link in the advert. However, should you have any questions please contact Elaine Kanwar at +41 61 282 22 23

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