Qualified Person Job Description Template
Our company is looking for a Qualified Person to join our team.
Responsibilities:
- Represent an area where required at Site Quality Review Group;
- Constantly drive to deliver high standards of GMP and general housekeeping;
- To assist in the implementation of CAPA’s and Change Controls;
- Ensure that all activities within the area are undertaken to established standards of cGMP;
- Compliance with relevant section of Directive 2017/1572;
- Provide Quality Assurance support on projects when required;
- To assist in the company supplier audit program;
- Foster and actively support a culture of continuous improvement;
- Managing, designing and implementing quality management systems for batch release operations;
- Member of senior management team contributing to site strategy;
- Support quality audits to ensure that external partner MA holder manufacturing sites are operating in compliance with EU GMP;
- Where required, deputise for the Lead Qualified Person;
- Review of change controls to ensure appropriate status for batch release;
- Coordinate quality assurance activities across the business relating to the dispatch of goods;
- Review of batch documentation.
Requirements:
- Good communication and interpersonal skills;
- Over 2 years experience acting as a QP in pharmaceutical/biological manufacturing businesses;
- 2 – 3 years of experience as a Qualified person (perfuming actively as a QP on licence);
- Eligibility as Qualified Person (UK);
- Current knowledge of requirements for GMP and GDP;
- Good working knowledge of requirements for GMP and GDP;
- Independent thinking and planning for self and others.