J4690OxfordEngineering Permanent£35,000 to £45,000 per annumFull Time06/12/2017Engineering Engineering – Quality Engineering – Validation
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An exciting opportunity for a Validation Specialist to join a leading company based in the Oxfordshire area has become available. As the Validation Specialist you will be responsible for all aspects of validation in a manufacturing and laboratory environment in accordance to Eudralex Volume 4, annex 11 & FDA 21CFR Part 11.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Validation Specialist will be varied however the key duties and responsibilities are as followed:
1. You will support the validation of equipment, facilities, utilities and processes in accordance with GMP requirements and execute validation protocols (DQ/IQ/OQ/PQ).
2. You will prepare and maintain validation master plans (VMPs), assist system owners with impact assessments and identify validation requirements where necessary.
3. You will manage the re-qualification of systems and equipment in accordance with approved plans and procedures to maintain the validated state' to support the company's validation efforts.
4. You will ensure compliance with safety, health and environmental (SHE) legislation and represent the Validation Department during client audits and regulatory inspections.
To be successful in your application to this exciting opportunity as the Validation Specialist we are looking to identify the following on your profile and past history:
1. Relevant degree in a life science or engineering discipline or equivalent.
2. Demonstrable validation experience in a biopharmaceutical, pharmaceutical or related industry including Manufacturing/Laboratory Equipment, Facilities & Utilities Qualification (URS, DQ, IQ, OQ & PQ)
3. A working knowledge and practical experience with aseptic processing and clean room validation
Key Words: Validation | Facilities | Utilities | Process | CSV | Computer System | GMP | GDP | GLP | GEP | IQ | OQ | PQ | DQ | URS | Manufacturing | Laboratory | VMP | Biopharmaceutical | Pharmaceutical | Cleanrooms | Equipment
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for our talent development. We welcome applications for any applicant who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment processionals and scientists. We look forward to helping you with your next career moves.