QA Validation Specialist - Kerry The successful QA Validation Specialist will be qualified with a BSc or equivalent academic qualifications with previous Industrial/pharmaceutical experience an advantage.
Strong reviewing skills and attention to detail to ensure right first time with Gx P Validation or validation governance experience an advantage.
Gx P Change Control experience also an advantage.
Duties: Involvement in the development, improvement and control of Gx P validation activities.
QA Final approval compliance governance function.
Reviewing and approving validation documentation, e.g.
User Requirement Specifications, Validation Plans, OQ, PQ, Validation Protocols/ Reports, Qualification Data etc.
Ensuring compliance with AICL(KP) procedures and regulatory requirements.
Participation in project teams to advise and assist in ensuring that validation documentation is written and executed in accordance with internal validation procedures, policies and adheres to the principles of c Gx P.
Familiarisation with developments, evolving regulatory requirements and innovations in validation requirements.
QA Management of site Gx P change control processes, ensuring maintenance of Gx P compliance, procedural compliance and of the validated state.
QA Management of Computerised System Periodic Reviews to ensure maintenance of the validated state.
Generation of the site Product Quality Reviews for Gx P change control activities.
Biannual Trend Review of Gx P site change controls.
Arcadis is a leading Project Management and Engineering Company delivering Full-Service Engineering with a client first mentality and personal touch across a range of market sectors: Project and Programme Management, Procurement, Design, Construction Management, Health & Safety Management, Commissioning, Qualification and Start-up.
We have one goal: to deliver more than our clients expect first time, every time.
Arcadis is an Equal Opportunities Employer.
Recruitment Agencies: Please do not reply to this job advert.