You will join the Global leader in Engineering and R&D Services (ER&D), offers its clients a new way to innovate by developing the products and services of tomorrow. You will be working alongside its clients on every link in the value chain of their project, from conception to industrialization.
Computer System Validation - CSV
Lead validation activities of Computerized Systems in the Life Sciences Industry
Assist in maintaining equipment automation systems in a validated state as they relate to GxP CSV automation systems.
Execute QA reviews and approvals of IT SOPs, and validate master plans for computerized system implementations.
Develop an appropriate document control capability and ensure all documents filings and archiving systems are accurate, up to date and maintained in accordance with GMP and other relevant regulations.
Establish and ensure good and close working relationship with important project stakeholders and internal customers.
Master in engineering, IT, Science or Computer related discipline.
5 years Proven track record in Computer System Validation in Pharmaceutical or Life Science environment.
Strong project management skills with the ability to prioritize assignments
Familiar with GxP systems.
Fluent knowledge of GAMP 5, Annex 11, CFR Part 11 Compliance and CFR Part 210, 211 & 820 compliance.
Excellent analytical and problem solving skills.
Able to cope with complexity, autonomous and pro-active.
Willing to work in an international environment.
Languages: English fluent and German is a plus
A permanent contract with the leader in innovation and high-tech engineering consulting
A multi-stage model with career opportunities through specialization prospects, as well as through continuing professional education and training
A steep learning curve due to diverse and cross-industrial project opportunities
An open and constructive corporate culture with over 30,000 colleagues in over 20 countries.
Helping clients to realize ideas from ideation, prototyping, industrialization of products, manufacturing, scale-up, distribution as well as service provisioning/support
Global projects & global job opportunities
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