An exciting opportunity for a Process Validation Specialist to join a leading company based in the Oxfordshire area has become available. As the Process Validation Specialist you will be responsible for all aspects of Process Validation in a manufacturing and laboratory environment in accordance to Eudralex Volume 4, annex 11 & FDA 21CFR Part 11.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Process Validation Specialist will be varied however the key duties and responsibilities are as follows:
1. You will support in the processes and cleaning validation in accordance with GMP requirements and a lifecycle approach in coordination with multi-functional Validation working parties. Liaising with internal functions including Engineering, Manufacturing, QC, QA and Manufacturing Development.
2. You will prepare and maintain validation plans (VPs), assisting system owners with impact assessments and identifying validation requirements.
3. As the Process Validation Specialist you will critically review the results of validation studies and effectively managing/closing-out any deviations, and represent the Validation Department during client audits and regulatory inspections.
4. You will lead process validation related activities for the design, qualification and continued process verification of the organisation's manufacturing processes, including identification of opportunities for improvement.
To be successful in your application to this exciting opportunity as the Process Validation Specialist we are looking to identify the following on your profile and past history:
1. Relevant degree in a Science or Engineering related discipline or a broad knowledge of biopharmaceutical and pharmaceutical industry regulations and guidelines including GMP, GDP, GLP, GEP.
2. Proven industry experience in Process validation, with experience in a biopharmaceutical, pharmaceutical or related industry including Manufacturing/Laboratory Equipment, Facilities & Utilities Qualification (URS, DQ, IQ, OQ & PQ)
3. A working knowledge and practical experience with Eudralex Volume 4, annex 11 & FDA 21CFR Part 11.
Key Words: Process | Equipment | Validation | Manufacturing | Biopharmaceutical | Pharmaceutical | IQ | OQ | PQ | URS | Annex 11 | GDP | GMP | GLP |
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.
You must be eligible to work in the UK. Learn more
- Agency: Hyper Recruitment Solutions
- Posted: 17th April 2018
- Expires: 15th May 2018
- Reference: J4690