J4663Field Based Pharmaceutical Biotechnology CRO/CMO Permanent£75,000 to £90,000 per annumFull Time31/10/2017Quality Assurance Quality Assurance – Qualified Person (QP) Quality Assurance – Auditing Quality Assurance – Compliance Quality Assurance – GMP Quality Assurance - Biologics
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We are currently looking for a Quality Operations QP to join a leading company based in the South East area. As the Quality Operations QP you will be responsible for leading the Quality Assurance team, including Qualified Persons, to drive compliance of the operational areas to regulatory and company requirements.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Quality Operations QP will be varied however the key duties and responsibilities are as follows:
1. You will maintain a thorough understanding of international regulatory guidance, Client, ISO and Corporate requirements, ensuring that all work within the QA department and across site are compliant to these.
2. You will lead, motivate and manage the Operational Quality Assurance team, providing leadership and guidance to QA Officers and Qualified Persons (QP). You will help in the development, KPI's, targets and objectives of the team, helping drive morale.
3. As the Quality Operations QP, you will represent the site on product quality matters by having effective communication with regulatory authorities, internal and external customers and agencies.
4.You will also be tasked with Qualified Person (QP) duties, releasing commercial batches. Upon request, you will also assist with the release of IMP products.
To be successful in your application to this exciting opportunity as the Quality Operations QP we are looking to identify the following on your profile and past history:
1. Eligibility to act as a Qualified Person as defined in 2001/83/EC and 2001/82/EC
2. Proven industry experience leading and developing Quality functions and teams.
3. A strong working knowledge of the principle and guidelines for GMP regulations. Knowledge of GxP would be advantageous.
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer that is happy to 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 scientists supporting science. We look forward to helping you with your next career moves.