J4567Bridgend County BoroughPharmaceutical Engineering PermanentFull Time10/10/2017Engineering Engineering – Validation
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An exciting opportunity has become available for a Validation Manager to join a leading pharmaceutical organisation based in the South Wales area. As the Validation Manager you will be responsible for the development and implementation of the strategies for the qualification of the new manufacturing unit and equipment including compliance to GMP, specifically Eudralex Annex 11 & 15 and relevant FDA guidance for industry.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Validation Manager will be varied however the key duties and responsibilities are as follows:
1. Lead the validation activities as part of the facility design, build and qualification project by hands-on work and support from specialist contractor(s) as required.
2. Support FATS, SATs, IQ/OQ/ PQ/DQ as appropriate of plant and equipment, reviewing documentation and advising team members to deliver best practice as well as draft and review GMP documentation including validation documentation, SOPs, and training documentation.
3. As some validation activities will be outsourced, you will maintain these relationships, monitoring KPIs so that performance and value for money is maintained.
4. As a key member of the Quality Team, contribute to the overall validation strategy for the site. Participate in and respond to inspections by Regulatory Authorities including MHRA and FDA, representing the validation function.
5. In addition to the contractors, manage other validation team member(s), including their performance, development, training and compliance.
To be successful in your application to this exciting opportunity as the Validation Manager we are looking to identify the following on your profile and past history:
1. You will have a relevant degree qualification or equivalent in a scientific, engineering or related discipline.
2. The successful candidate will have experience of leading and conducting validation activities in a GMP licensed facility that includes aseptic and/or sterile manufacturing.
3. You will have proven experience of manufacturing compliance to GMP regulations and guidance including specifically Annex 11 & 15. Current working knowledge of GMP, and with a deep understanding of validation of cleanroom manufacturing environments and related 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.