Technical Affairs Coordinator QA/RA - Pharmaceutical

We are delighted to be exclusively supporting a start-up pharmaceutical business with excellent growth plans to recruit a Technical Affairs Coordinator (QA/RA) role.
  
The business:
Our client have been around for less than 5 years and operate within a niche area of the generics pharmaceutical sector. They have quickly established themselves as a strong player in this space, supplying a range of products across the industry. Whilst fairly early into the business journey, the leadership team have focused on putting the building blocks and foundations in place to sustain a long-term and viable business. They have seen strong commercial performance over the last few years, but ensured that the business is financial sustainable and in a good place to support people achieve long-term career development and progression.
  
This next phase for the business is solely geared around growth and scaling the business to the next level. Having supported them with key hires, we can see that the continued investment in personnel is a key catalyst to this and none more so than the hiring of Technical Affairs Coordinator role currently being recruited.
  
The opportunity:
Whilst still a small business in the industry, there are some fairly major plans and ambitions in place, so it is equally important the individuals joining the business at this early stage are up for the challenge that lies ahead. The Technical Affairs Coordinator must be prepared to roll their sleeves up and actively contribute to the overall growth of this business.
  
Your role will be highly technical but equally varied in nature, effectively being responsible for both Quality and Regulatory activities within the company - you will have a great level of exposure to people at all levels, both internally and externally and play an active role in ensuring the continued compliance of the business moving forward.
  
The key responsibilities for the Technical Affairs Coordinator (QA/RA) will involve the following:
  
Quality

• Perform monthly Bona fide checks of customers.
• Manage and co-ordinate supplier qualifications.
• Support QP/RPI for batch releases.
• Liaise with customers and suppliers for issues and investigations.
• Manage SOP training matrix and Ensure SOP trainings of all employees
• Manage vendor/supplier audit schedule.
• Prepare and share sampling plan and testing plans with warehouse and the UK testing lab respectively
• Provide any other QA support as needed

Regulatory

• Arrange information needed for variation filing
• Manage variation tracker
• Co-ordinate with suppliers, regulatory team, and artwork vendor for artwork or mock-ups
• Provide co-ordination support during regulatory filing of MAAs
• Provide any other regulatory support as needed

  
The ideal candidate for the Technical Affairs Coordinator role will have the following background:

• Degree qualified in a Scientific discipline.
• Prior experience working in a technical role encompassing Quality Assurance or in Regulatory Affairs in the Pharmaceutical industry.
• Experience and understanding of Pharmaceutical Quality System requirements i.e., CAPA, Change control, risk assessments, Validation, etc.
• A can-do, proactive approach to work, with the ability to work both independently as well as collaboratively with cross functional teams.

Keywords: Technical Affairs Coordinator, Quality and Regulatory Officer, QA/RA Officer, Quality Officer, Quality Specialist, Quality and Regulatory Specialist, QA/RA Specialist, Pharmaceutical
  
PLEASE NOTE - OUR CLIENT ARE UNABLE TO PROVIDE ANY VISA SPONSORSHIP AT THIS STAGE. WE ARE THEREFORE ONLY ABLE TO CONSIDER CANDIDATES WHO ALREADY HAVE FULL RIGHT TO WORK IN THE UK.