We are currently supporting a Pharmaceutical business with the search for a new Qualified Person (QP) to join their team at an exciting phase of growth.
The business:
Our client is an established pharmaceutical organisation, part of a larger group of businesses, providing services to a diverse customer base in the UK. Having experienced significant increases in volumes in recent times, there is a need to bring on board a new permanent QP.
The role:
The Qualified Person will work on site and will be responsible for performing QP batch release and supporting the day-to-day operation of the Quality Management System. You will also perform QP batch certification and meet QP duties as per GMP Annex 16.
The Qualified Person will work alongside the Senior Leadership Team as well as the QA team to ensure effective functioning of the Pharmaceutical Quality System.
Key Responsibilities for the Qualified Person job:
* Carry out the duties as described in the QP Code of Practice and Eudralex Volume 4 GMP guideline for QPs (Annex 16).
* Undertake and perform all Qualified Person (QP) activities ensuring adherence to the site's Manufacturing Licence (MIA) and Marketing Authorisations.
* Undertake routine product certification as a Qualified Person in accordance with article 51 of 2001/83/EC and Annex 16 of Good Manufacturing Practice Part I (EudraLex volume 4).
* Assist and lead in maintaining GMP & GDP standards across all site operations.
* Participate in the internal audit schedule.
* Conduct audits of vendors, where required, and approve Technical Agreements with service providers.
* Host regulatory inspections and manage the audit report responses.
* Perform the review and certification as suitable for release for sale batches of product processed at the site.
* Ensure timely QP certification for release of all products.
* Review and approve Standard Operating Procedures and other relevant GMP documents relating to the manufacture, labelling and assembly operation, storage, and distribution of medicinal products.
* Support deviations, CAPA, change control, complaints, recalls, risk assessments, re-works, and adverse events.
* Provide support to Regulatory Affairs.
* Undertake relevant project work as required, involving improvement of QA systems and processes.
* Provide input (and participation) into the Management Review process.
* Ensure suitable arrangements are in place with suppliers for products e.g. WDAs.
* Ensure validation and qualification requirements are met, where appropriate.
* Advise Senior Management if there are any significant GMP compliance risks ensuring the business is meeting cGMP requirements relevant to this industry e.g. Data Integrity, FMD/safety features.
The successful candidate for the Qualified Person role will have the following background:
* Scientific Degree (Preferably in a pharmaceutical or chemistry discipline).
* Eligible QP with substantial industry experience within the Pharmaceutical sector.
* High volume batch release experience and a track record of CPD within industry.
Keywords: Qualified Person, QP, Head of Quality, Trainee QP, GMP
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Quality Assurance
Industries
Pharmaceutical Manufacturing
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