Title: QA Validation Specialist/Lead
Location: North East of England
Salary: £35,000 - £42,000 per annum with a really attractive benefits package
SRG are currently working with a very well-established organisation, which is responsible for technical innovations across the UK in different scientific sectors including pharmaceuticals and biologics, who are currently looking to further expand their quality department. As the organisation have recently developed a brand new GMP manufacturing facility, The focus of this role is to assist in the development and implementation of the validation strategy for the qualification of high-profile projects and their equipment to a current GMP compliant standard; this includes process utilities, process equipment and computer systems.
This organisation is a leader in scientific innovation, mainly looking at providing scientific support around process, development and product improvement working across multiple sites. Founded in 2004, they have been behind some of the UK's biggest scientific innovations.
- To develop and implement validation policies, protocols and standard operating procedures.
- To deliver and maintain compliance to a GMP standard and specifically to the requirements of Annexes 11 & 15 of EudraLex Volume 4 and taking into account ICH Q9 and ISPE Codes/Guides.
- To work with the technical teams, adopting a risk management approach with operations to define and implement the overall validation strategy for the function.
- To review and approve the validation and qualification activities associated with: the facility qualification and its utility systems; the establishment of the process equipment; and with ongoing operations.
- Support the site Pharmaceutical Quality System including input into investigations and/or CAPAs.
- Possess significant quality system and validation expertise and experience of operating within a GMP environment, developing and implementing and monitoring quality systems and validation programmes.
- Knowledge of ISO 9001 quality management systems and standards.
- Knowledge of EU GMP Guidelines, including Annexes 1, 2 & 15.
- Experience in the use and implementation of electronic document management systems and QMS.
If you would like to apply for this position, please use the link provided. Alternatively please email a copy of your CV to firstname.lastname@example.org. For more information regarding this position or any others, please call Behruz on 0161 868 2202.
SRG are the UK number 1 recruitment company specialising in the science, engineering, clinical, pharmaceutical, food/FMCG, renewable, biotech, chemicals and medical devices sectors.
As scientists ourselves, our specialist sector knowledge and our passion are second to none. It's this combination that makes us different. We're committed to providing outstanding temporary, contract and permanent career opportunities of all levels for our candidates and a comprehensive range of expert strategic recruitment services for our clients.
If you have a scientific background and this position is not relevant / suitable for you please feel free to get in touch or visit www.srgtalent.com to view our other vacancies.
Keywords: QA, Quality Assurance, QA Officer, CAPA, Deviation, GMP, QA Validation, validation protocols, EU GMP Guidelines, Annex 1, 2 & 15.
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- Agency: SRG
- Reference: J2162769
- Posted: 24th November 2021
- Expires: 1st December 2021