Contract Qualified Person QP - Pharmaceutical

We are currently supporting a Pharmaceutical business to bring on board an additional Contract Qualified Person (QP) to support their Quality team.
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 for an additional Contract QP on site.
The role:
The Contract QP will be responsible for performing QP batch release and support with 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.
You will work alongside other Contract QP's, 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)
* Undertaking and performing all Qualified Person (QP) activities ensuring adherence to the site's Manufacturing Licence (MIA) and Marketing Authorisations.
* To 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
* Participation in the internal audit schedule
* Audits of vendors, where required, and approving Technical Agreements with service providers.
* Hosting regulatory inspections and managing the audit report responses
* To perform the review and certification as suitable for release for sale batches of product processed at the site
* Timely QP certification for release of all products
* Reviewing and approving 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
* Providing support to Regulatory Affairs
* Undertaking relevant project work as required, involving improvement of QA systems and processes
* Provide input (and participation) into the Management Review process
* Ensuring suitable arrangements are in place with suppliers for products e.g. WDAs
* Ensuring validation and qualification requirements are met, where appropriate.
* Advise Senior Management if there are any significant GMP compliance risks ensuring the business are 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: Contract QP, Contract Qualified Person, Qualified Person, QP, Head of Quality, Trainee QP. GMP