Job Description

Are you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries PQE Group has been at the forefront of these industries since 1998 , with 40+ subsidiaries and more than 2000 employees in Europe, Asia and the Americas . Following a new opportunity, we are currently looking for a CSV - Consultant / SC /PM to join our team for a project at Bengaluru Location . Responsibilities include, but are not limited, to the followings: Working on IT Infrastructure usage i.e. Servers & Network Devices Functional understanding of Manageable Network device i.e. Routers, Firewall, Switches (Cisco/Avaya), Access Points. Should have experience on Agile methodology. Handling of Network Administration will add benefit to profile. Working on CSV Concepts including IT Infrastructure Qualification. Regulatory guidelines (i.e. 21CFR Part 11, EU Annexx 11) and requirements of Infrastructure Qualification. GAMP5 Guidelines. Handling and working on Validation Testing tools will add benefit to profile. Resolution of fundamental Computer System Validation compliance issues on assigned projects Writing, reviewing and executing computer validation documentation Primarily accountable for the validation of compurterized systems, in accordance with GAMP5 and V-Model (USR, Function Specification, IQ/OQ/Protocol/Report/Testing, Traceability Matrix, Validation Report) Very good knowledge of Data Integrity Assurance according to EU GMP Annex1, US FDA Annex 11 and relevant predicate guidances Capable to assess electronic/paper records aiming to identify Data Integrity gaps with Risk-Based Approach and suggest the most appropriate mitigation/remediation actions Ensure all project-related issues and deviations are recorded, approved and dispensed accordingly (including ensuring proper deviation report preparation and approval) Preparation of project and life-cycle reports and review/approve all other documents to ensure compliance with SOP Ensure all project and lifecycle documents achieve the goal of traceability, and these are all retained in the document repository (Document Navigator) and approved following the prescribed SOP Must have previous experience validating systems of Pharmaceuticals ( Lab Systems, Manufacturing Systems, Applications and Software) Proficient in understanding of GxP regulations and validation principles Requirements: - Bachelor\'s Degree in Science or Engineering (Computer Sciences, Engineering, Informatics, Chemistry, Biotechnology, Physics, Mathematics) At least 5 -13 Years of experience in Computer Systems Validations supporting GMP regulated environment (Life Science / Pharmaceutical Manufacturing Sector) Fluent in Spanish and English, conversational and written (any additional language will be considered a plus) Integrity, strong ethics, analytical skills and attention to details Full availability to travel Location: Bengaluru, India As a member of the PQE team, you will be part of a challenging, multicultural company that values collaboration and innovation . PQE Group gives you the opportunity to work with International colleagues in all over the world. If you are looking for a rewarding and exciting career , PQE Group is the perfect place for you. Apply now and take the first step towards an amazing future with us.

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