Computer System Validation Specialist
Candidates for this position will be responsible for ensuring the ongoing validation compliance of computerised equipment and systems. The ideal candidate will have a strong background in computer system validation, with experience in managing validation projects and ensuring compliance with relevant regulations.
* Integrally involved in the validation of all new computerised equipment, and control systems.
* Generates validation documentation (protocols/reports) and provides assistance with the execution of protocols for computerised equipment and systems.
* Participates in the change control process advising on CSV issues, as appropriate.
Responsibilities:
* Hands-on role in the development and execution of DQ, IQ, OQ and PQ activities.
* Ensures projects are managed in compliance with all required Company and legal requirements (Health & Safety, c GMP, construction, environmental etc).
* Designs, implements and executes validation studies for manufacturing and control equipment.
Qualifications:
* Post-graduate degree in Science or Engineering (Chemical/Mech/Elec)
* 3-5 years of experience working in a Healthcare manufacturing environment, preferably in the pharmaceutical sector
* Project management experience and ability to troubleshoot validation issues associated with projects, process development etc
* Full understanding of relevant quality and compliance regulations
Skills:
* Computer System Validation GAMP PQ DQ OQ
Additional responsibilities include critical systems and facilities as well as validation studies to satisfy regulatory compliance. The successful candidate must possess excellent technical knowledge of pharmaceutical plants and a thorough understanding of GAMP and ISPE guidelines.
Benefits:
* Competitive salary range based on experience
* Opportunity to work with a dynamic team and contribute to the success of the company
Key Qualities:
* Strong problem-solving skills and ability to work independently
* Excellent communication and interpersonal skills
* Ability to prioritize tasks and manage multiple projects simultaneously