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Job titleQARA Manager
Job typeMeditech
Salary GBP Yearly
LocationUK South
Bonus Package
Job description

Are you an MHRA registered Responsible Person? Do you have experience in manufacturing, testing and quality assurance of sterile products? A global ophthalmology company are looking for a Pharmaceutical QARA Manager to work on lifecycle management in Europe.
 

The company

Our client has worked closely with cataract surgeons throughout their history to lead the way in the innovation of pharmaceutical and medical ophthalmic devices, making them key market player in the development of new products and ocular therapeutics. Passionate about improving sight worldwide, they focus on achieving the very best in patient-care.

This is supported by a strong Research and Development branch who are constantly working on developing new products using their extensive technical expertise.
 

The role

Regulatory affairs is one of the biggest areas in the medical device space right now. In this role your core focus will be ensuring that all GDP activities are compliant with quality regulations as well as supporting the wider business by organising resources and processes. You’ll make sure that the company’s pharmaceutical branch is fully compliant with the latest regulations.

Responsibilities include:

  • Ensure all GDP activities are fully compliant with regulations
  • Ensure Wholesaler dealing licence is retained
  • Be the Responsible Person (as defined by guidelines on GDP practice of medicinal products (2013/C 343/01))
  • Ensure the company and their products are fully compliant with EU, FDA and National Quality regulations
  • Liaising with the leadership team on any supply, quality, or safety issues
  • Leading due diligence on new product opportunities
  • Leading non-clinical product development for the pharmaceuticals branch of the company
  • Look after medical affairs activities
  • Complete regulatory filings in agreed timescales
  • Manage external relationships

 

The requirements

You will be registered with the MHRA as a Responsible Person for WDA as well as…

  • Bachelor’s Degree in life science (or equivalent professional qualification)
  • Strong understanding of manufacturing, testing, and quality assurance of sterile products
  • Understanding of pharmacoviligance requirements
  • Knowledge of FMD processes in pharmaceutical manufacturing
  • Experience in a similar role
  • Knowledge and experience of imports and exports of pharmaceutical products
  • Experience as a quality leader in the pharmaceutical space would be desirable
  • Knowledge of the regulatory environment
  • Able to review product literature and make regulatory recommendations
  • Experience of ophthalmic products is desirable but not essential

 

Important information

FMC Contact for this role: Ryan Tosh ryan.tosh@fmctalent.com)             

Reference number: 8657

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Updated on 2017-08-07T17:04:38+00:00, by Matthew Graham.