J4529HertfordshirePharmaceutical Contract / Temporary / Interim£330.00 to £340.00 per dayFull Time10/10/2017Quality Assurance - Validation Engineering
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We are currently looking for a Validation Specialist to join a leading Pharmaceutical company based in the Hertfordshire area.
As the Validation Specialist you will be responsible for Validation activities associated with commissioning and start-up activities. This will include Critical Systems, Utilities, Equipment, Facilities, Laboratory Equipment, HVAC, CSV.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Validation Specialist will be varied however the key duties and responsibilities are as follows:
1. Assist in the authoring of User Requirement Specifications, Design / Installation /Operational / Performance Qualification protocols and reports for validation purposes. (Validation project execution DQ/IQ/OQ/PQ).
2. Be involved in the implementation of a risk based approach to the validation of systems including computerised systems in accordance with EU GMP Annex 11, 15 and GAMP 5, along with company quality documents and guidelines.
3. Provide a strong understanding of utility systems, process instrumentation, automation systems, and analytical equipment.
4. Interface / Communicate with Facilities, Quality, Operations and Information Technology groups to develop requirements, establish programs and manage day-to-day operation.
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 Sciences or Engineering discipline
2. Proven industry experience in the Pharmaceutical / Biopharmaceutical industry with Validation and Quality Compliance (cGMP, ICH, FDA, USP, EP policies / guidelines).
3. A working knowledge and practical experience with interacting with regulatory authorities, clients and collaborators.
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.