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An exciting opportunity for a Validation Specialist has become available with one of our Biopharmaceutical clients based in the Greater London area. As the Validation Specialist you will be responsible for performing validation activities across the manufacturing facility, as well as support multiple validation projects with project teams and associated departments.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Validation Specialist will be varied however the key duties and responsibilities are as followed:
1. Authoring, executing and reporting validation activities within the framework of cGMP - Annex 11 & 15 and in compliance with the organisation's QMS requirements.
2. You will undertake validation project execution (DQ/IQ/OQ/PQ) in conjunction with relevant stake holders ensuring timelines are met and deliverables achieved.
3. You will supervise validation testing performed by vendors to ensure work is complete and accurate, and work with vendors for issue resolution and validation deviation reporting.
4. You will adhere to the client's Change Management System for all changes to existing or implementation of new systems
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 or equivalent and knowledge in validation and quality compliance (cGMP/ICH/FDA/USP/EP policies/guidelines).
2. Proven industry experience in Validation in Biopharmaceutical environment, or a combination of Validation and Engineering/Commissioning experience.
3. A working knowledge and practical experience with interfacing with Facilities, Quality, Operations and Information Technology groups to develop requirements, establish programs and manage day-to-day operation.
Key Words: Validation | Compliance | VMP | Facilities | Utilities | Process | Equipment | Computer Systems | Operations | GMP | Manufacturing | IQ | OQ | PQ | DQ | Validation Master Plan | VMP | Annex 11 | Annex 15 | Cleaning | HVAC | QMS | Quality Management Systems
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.