Job Reference: FRS56541
Job Duration:
Start date:
Description:
Validation Manager - Pharma
I am delighted to be supporting myclient, a leading life sciences company in recruiting a Validation Manager to join their team in Waterford.
Reporting to theHead of Quality, you will be responsible for ensuring compliance with GMP validation requirements by developing and implementing programs for laboratory computerized systems, instruments, equipment, and operational systems.
Responsibities: (A snapshot…)
* Stay current with client, EU, FDA and GAMP validation expectations, regulations, and requirements; interpretregulations and coordinate implementation into internal practices
* Subject Matter expert equipment validation lifecycle including computerised system
* Determine approach to validate specific laboratory systems and laboratory instrumentation
* Provide training, trouble-shooting, technical and/or regulatory support to laboratory personnel
* Research instrumentation with information obtained from vendors, manuals, industry resources, and other staff performing similar functions
* Write and/or assist technical groups in writing validation protocols, test scripts, and related documentation in accordance with established validation program; review and approve documents written by other validation personnel for approach, GMP compliance, completion, consistency, and compliance to internal validation procedures
* Accurately maintain all administration aspects of instrument validation program including but not limited to inventory reports, change control program, scheduling, database updates, and follow-up reports
* Complete instrument vendor evaluations to assess level of compliance; write reports to communicate vendor statusto management
* Participate in internal, client, and regulatory audits; develop audit responses and corrective actions as necessary
* Performs other duties as assigned
Requirements
* At least 5 years' experience in validation and support of pharmaceutical laboratory instrumentation and systems
* Good team player, organised, accurate, have strong documentation skills* Passionate about quality and client service
* Good communication skills both internally and externally.
* The ideal candidate will be highly motivated, high achiever with strong project management skills to develop clear project plans and to completeprojects within agreed timelines.
For a confidential discussion and to review the Job Description Apply Now or contact Kerry on 086 044 3981
Industry: Pharmaceuticals
Salary: €70000 - €75000 per annum + Healthcare, Pension, Bonus,
Salary Benefits: Healthcare, Pension, Bonus,
Vacancy Type: Permanent
Job Skills: Validation, Instrumentation, Equipment IQ, OQ, PQ
Contact Name: Kerry Rickard
Website: -
Direct Application URL: -