Qualified Person (QP) - Pharmaceutical

Little Hulton
2 months ago
Applications closed

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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 for an additional 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 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.
  
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)
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: Qualified Person, QP, Head of Quality, Trainee QP. GMP

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