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Hyper Recruitment Solutions
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Qualified Person - ATMP

Permanent
Experience Dependant
Job Reference: J5632822
Updated On: 28/01/2020
Status: Open to Applications
Hyper Recruitment Solutions
Sectors: Cell & Gene Therapy

Skills: Quality Assurance - Qualified Person - Permanent, Quality Assurance - Permanent, Quality Assurance - GMP, Quality Assurance - Quality Manager, Quality Assurance - ATMPs

Job Information

Role Overview

We are currently looking for a Qualified Person to join an ATMP company based in the South East. As the Qualified Person you will be responsible for assisting with the development of the Quality Assurance team to drive compliance of the operational areas to regulatory and company requirements, as well as batch release of ATMP's.

Key Duties and Responsibilities

Your duties as the Qualified Person 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 support 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 Qualified Person, 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 sterile batches.

Role Requirements

To be successful in your application to this exciting opportunity as the Qualified Person 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.


Key Words: Quality Operations | Quality Assurance | Qualified Person | QP | GMP | GXP | QMS | Commercial | IMP | Management | Team | QA | Operational Quality | Audit | Leadership | Technical
Chris Carey
Your Recruitment ConsultantChris Careychris.carey@hyperec.com
DisclaimerHyper 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.