Description
Reference Nr.: 915538NC
Sector: Pharmaceutical
Location: Southern Ireland
Start: ASAP
Duration: 2-3 months ++
Job Type: Contract
Role:
We have a fantastic opportunity for a Validation Specialist Level III to get involved at the start-up of a new project. The primary purpose of this role is to lead validation activities of laboratory equipment and software. You will be a key point of contact for validation activities.
Responsibilities:
- Prepare the laboratory validation Master plan with regard to facilities, computer systems, equipment and instrumentation.
- Be a SME (Subject Matter Expert) on computer system validation
- Write and/or perform evaluations, reviews, risk assessments and testing for laboratory systems using in-house standard operational procedures
- Maintain up-to-date listing of all relevant systems and their GMP functionality
- Develop and define methods, techniques and evaluation criteria
- Stay current with client, EU and US FDA validation expectations, regulations, and requirements; interpret regulations and coordinate implementation into internal practices
- Write and/or assist technical groups in writing validation protocols and reports for the software and systems, user requirement specifications, change control and related documentation
- Develop and implement quality systems and procedures in conjunction with management to direct the validation life cycles; maintain validation policies and operating procedures in a current compliant state.
- Review and approve documents ensuring regulatory compliance, in-house procedure compliance completeness and consistency
- Deliver training to technical groups to ensure full understanding of the company validation requirements with emphasis on the content of the validation master plan, validation template documents, internal procedures and management of validation changes.
Skills/Experience:
- At least 3 years' experience in validation and support of pharmaceutical laboratory instrumentation and systems
- Strong project lead skills to develop clear project plans and to complete projects within agreed timelines.
- Good team player, organised, accurate, have strong documentation skills
- Passionate about quality and client service
- Good communication skills both internally and externally.
Qualifications:
- Bachelor's degree in computer science, chemistry, biochemistry, microbiology or engineering preferable