QA CSV Specialist

Job Description

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 100,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, AppliedBiosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon.

We are looking for a QA CSV Specialist onsite in Allschwil. www.fisherclinicalservices.com

Responsibilities:

• Serve as Quality reference for IT in regard to Validation of IT systems

• Participate in the review and approval of plans and reports related to the qualification (requalification) & validationURS,FAT, SAT, Risk analysis, IQ, OQ, PQ, computerized systems.

• Control the smooth running of qualification & validation operations in the field to ensure that the systems are operational and in a state of permanent validity.

• Tracks execution of periodic review in a timely manner

• Participate and Track the performance of Audit trail reviews of computerized Systems

• Generation of templates for CSV activities

• Approve SOPs, change requests and deviations related to computerized systems

• Ensure compliance with Data Integrity requirements

• Participation as internal auditor for inspections

• Represent CSV QA in Client Audits

Qualification:

• Experience in pharmaceutical industry computer system validation

• Knowledge of pharmaceutical GMP environments

• Strong written and verbal communication skills, excellent interpersonal skills and an ability to work with diverse groups of people

• Fluent in English, German also preferred

• Problem solving skills

• Proven team working ability