Validation Specialist

REFERENCE NR.: 915054

SECTOR:Pharma

LOCATION: Southern Ireland

START:ASAP

DURATION: 12 months

JOB TYPE: Contract

ROLE:

We have a fantastic opportunity for a VALIDATION SPECIALIST CONTRACT. The primary purpose of this role is to lead validation activities of laboratory equipment and instrumentation. You will be a key point of contact for validation activities.

QUALIFICATIONS:

- Bachelor's degree in computer science, chemistry, biochemistry, microbiology or engineering

RESPONSIBILITIES:

- Prepare the laboratory validation Master plan with regard to facilities, computer systems, equipment and instrumentation.
- Be an SME (Subject Matter Expert) on computer system validation
- Write and/or perform evaluations, reviews, risk assessments and testing for computerized laboratory systems considering the principles of GMP, namely, 21 CFR Part 11 EU Annex 11 and 15 along with in-house procedures
- Maintain up-to-date listing of all relevant systems and their GMP functionality
- Develop IQ, QQ, PQ and URS templates for the laboratory
- 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, user requirement specifications, change control and related documentation in accordance with established validation program
- 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 GMP 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
- 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 complete projects within agreed timelines.

CLOSING DATE FOR CVS: 14th June 2015