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Quality Assurance Specialist – BAP Pharma UK

 

Marlow, Buckinghamshire, UK

Salary: Competitive base salary + performance based bonus

Hours: Full Time

Contract Type: Permanent

Experience Level: Experienced (non-manager)

 

Overview

 

If you’re an experienced pharmaceutical quality assurance professional who’s open to an opportunity with a  highly successful and growing specialist pharma business you should read on.

 

The company

 

BAP Pharma is a global leader and still fastest growing company involved in the supply, packaging and labelling of medicines used in ground-breaking clinical trials. Now in our 10th year of trading, we will smash our targeted turnover of more than €250M in 2021, with more growth to come. We have grown on average at 45% per year in each of the last 2 years. And in order to maintain our growth, we have invested significantly in new sites globally. Currently moving to state of the art new facilities in both UK and USA, our German facility in Hochstadt, Bavaria, was purchased and massively modernised to its current state of art outlook in 2020. Come and join the team, develop your skills and grow as our exciting, development and expansion continues. We are now looking for a….

 

Overview of opportunity

 

You’ll be able to ensure that BAP Pharma is compliant with both GMP and GDP requirements and follow the guidance stipulated by the local health authorities MHRA and FDA.  This role will also ensure that BAP Pharma Ltd are fully compliant with the UK Home Office Controlled Drugs regulations at all times. In addition, manage BAP Pharma to be fully compliant to the requirements of ISO9001:2015.

 

Examples of key responsibilities

 

  • Ensure compliance to GMP and GDP regulations
  • Support the maintenance of QMS - CAPAs, deviations, change controls and complaints
  • Support the RP with ensuring BAP Pharma adhere to the Falsified Medicines Directive
  • Support the Goods-in and Goods-out processes
  • Writing, reviewing and approving SOPs within the Electronic Quality Management System
  • Support the RP during Product recall, complaint investigation, deviation and CAPA implementations
  • Support the supplier and customer verification programme/development
  • Support the RP during Self-inspections and external audits
  • Oversee the warehouse operations and ensure that temperature conditions are maintained, and seasonal mapping and calibration activities are conducted in a timely manner
  • Provide support during client and MHRA inspections
  • Provide support during internal staff training on GxP elements
  • To ensure that the provisions of the WDA(H) and MIA(IMP) are met at all times
  • Support the RP during validation activities (Preparation of documentation & execution of testing)
  • To manage the Quality Key Performance Indicators
  • Support the RP during Quality Management Review Meetings

 

Position Requirements

 

In essence we’re looking for someone with a  good broad understanding of GMP and GDP QA requirements who can cover a broad range of related activities.

 

As important as your technical background is your attitude; you’ll be diligent, committed to excellence and have a really great work ethic.  BAP can offer great ongoing career development opportunities as we grow and we’re looking for someone who recognises that opportunity and wants to build a long term career with us.

 

We regret that we are unable to consider home working or applications for people who do not have an existing right to live and work in the UK.

 

If this opportunity sounds like you and you’d like to make an application please apply here – your application will be acknowledged and processed promptly

To learn more about this role, please apply or contact Andrew directly on andrew.wise@bluepelican.com

How to apply

If this position is of interest please send us your CV here, or you can call Andrew Wise direct on to discuss this and other vacancies that may suit.

Andrew Wise

Email: andrew.wise@bluepelican.com