J562788CambridgeshirePharmaceutical Engineering Permanent£40,000 to £45,000 per annum - Dependent on Experience Full Time30/08/2018Biochemistry – Development / Validation Quality Assurance – Compliance Quality Assurance - Validation Quality Assurance – GMP Engineering Engineering – Validation Quality Assurance – CSV
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An exciting opportunity for a Validation Team Lead to join a leading pharmaceutical company based in the Cambridgeshire area has become available. As the Validation Team Lead you will be responsible for overseeing all activities performed by the Validation department, providing guidance to the team as required and ensuring that all validation procedures are in alignment with current regulatory requirements.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Validation Team Lead will be varied however the key duties and responsibilities are as follows:
1. You will develop and maintain the risk based validation plans and maintain the Site Validation Master Plan, as well as manage the Process Validation documentation process, through protocol generation, execution and final approval.
2. You will support the introduction and validation of new equipment, processes and products. As the Validation Team Lead you will assist in the development of documentation to support these activities, in compliance with company and project specific standards.
3. You will recruit and train a validation team, provide leadership and development, through creating plans to improve quality and efficiency of the organisations staff.
4. You will lead site preparation for regulatory audits from a validation perspective and monitor regulatory intelligence to ensure that the site has always appropriately/risk based assessments in order to meet the latest regulatory expectations.
To be successful in your application to this exciting opportunity as the Validation Team Lead 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 GxP. 2. Proven industry experience in 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: Validation | Team Lead | Facilities | Utilities | Process | CSV | Computer System | GxP | IQ | OQ | PQ | DQ | URS | VMP | Pharmaceutical |
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.