Validation and Qualification Consultant

Location
Oxfordshire
Salary
£50 to £65 per hour
Posted
10 Oct 2017
Closes
07 Nov 2017
Ref
J4560
Contact
Georgia St John-Smith
Contract Type
Contract
Hours
Full Time
We are currently looking for a Validation and Qualification Consultant to join a leading company based in the Oxfordshire area.

As the Validation and Qualification Consultant you will be responsible for setting up procedures and implementing a new Validation System for Clinical Trial Manufacture.

KEY DUTIES AND RESPONSIBILITIES:

Your duties as the Validation and Qualification Consultant will be varied however the key duties and responsibilities are as follows:

1. Using a Quality Risk Management approach, establish a revised policy and set of procedures (and SOPs) for validation and qualification activities for facilities, equipment, utilities and processes as is required.

2. Ensure compliance with EU GMP Annex 15 and EUGMP Annex 11 for any computerised systems.

3. Produce a set of master documents covering all aspects of validation including UserRequirement Specification (URS), Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ).

4. Compile the annual Validation Master Plan (VMP) and design / deliver specific training sessions for all staff on Validation.

ROLE REQUIREMENTS:

To be successful in your application to this exciting opportunity as the Validation and Qualification Consultant we are looking to identify the following on your profile and past history:

1. Relevant degree in a Life Sciences discipline

2. Proven industry experience providing Validation expertise in Pharmaceuticals, Biopharmaceuticals, or Clinical Trial Manufacture.

3. A working knowledge and practical experience with EU GMP guidelines (Eudralex Volume 4), the Medicines for Human Use (Clinical Trials) Regulations 2004 and its amendments, ICH Q9 and Q10.

Key Words: Validation / Qualification / Quality Assurance / QA / Technical Writing / SOP / Standard Operating Procedures / URS / DQ / IQ / OQ / PQ / Validation Master Plan / VMP / Clinical Trial Manufacture / Clinical Trials / Biopharmaceutical / Pharmaceutical / Biologics / Life Sciences / EU GMP / CSV / Computer System Validation / Regulatory Affairs / Auditing

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.

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