JOBS

Back

Qualified Person and Regulatory Compliance

November 19th 2019

QUALITY ASSISTANCE provides the pharmaceutical industry with all the analytical services required by EMA and FDA regulations for the development and marketing of innovative human medicinal products. Quality Assistance is a European benchmark company in the analytical sciences. With 35 years of expertise in the development and validation of analytical methods, cutting edge equipment and high level of Quality Assurance, Quality Assistance has gained the trust of the largest international pharmaceutical groups and numerous biotechnology companies based in Europe and the United States.

Mission Description

SCOPE

We assist our clients through non-clinical and clinical studies to marketing authorisation, using our state-of-the-art, product-dedicated expertise in analytical sciences.
For each customer and each project, we design customised solutions, define analytical protocols, develop and validate specific new analytical methods and perform characterisation, stability, pharmacokinetic, biomarker and immunogenicity studies as well as batch release testing, in order to evaluate the Quality, Safety and Efficacy of the given drugs.

YOUR MISSION

You will report to the Director Compliance and will be part of a team of 9 people

As Qualified Person you will be accountable for the following tasks 

  • Approving reports and Certificates of Analysis (CoA)
  • Reviewing and approving the quality contracts with the customers and the suppliers (Quality Agreement)
  • Maintaining the update of the regulatory authorizations of the site according to the activities performed
  • Approving  non-conformities, OOS and change controls
  • Managing Analytical methods (authorization release into the system)
  • Participating to suppliers, clients audits and regulatory inspections when needed 
  • Being the primary point of contact with Belgium Authorities 
  • Working closely with QA compliance team
  • Ensure Regulatory watch on all new Regulations impacting Quality Assistance scope of activities
    • Overseeing the updates of regulatory policies and procedures on different channels: the Moniteur belge, ICH, Eudralex, AFMPS, FDA, GMP compliance, pharmacopeia’s, …
    • Reviewing, analysing and interpreting regulatory requirements in a clear and concise manner
    • Dispatching/distributing regulatory information to internal stakeholders for review
    • Performing gap assessments for proposed and effective regulatory requirements
    • Leading Regulatory Committee Meetings.

Candidate profile

  • You have a Master’s degree in Industrial Pharmacy
  • You have been certified by FAMHP as a Qualified Person
  • You are 
    • Stress resistant and proactive
    • Meticulous and details oriented
    • Fluent in French with a good knowledge of English, both written and spoken 
  • You have 
    • Good organizational, planning and communication skills
    • Good ability to analyze and synthesize
    • Theoretical knowledge of physicochemical and molecular and cell biology analytical techniques
    • Good knowledge of the pharmaceutical sector, Quality Assurance principles, GMP and ICH guidelines

Offer

Quality Assistance offers you work in:

  • The innovative human health sector 
  • A growing evolving company
  • A rigorous dynamic team
  • An international working environment
  • Spacious premises in pleasant surroundings 

Quality Assistance also provides:

  • In-service training adapted to your profile and position 
  • Career path
  • A sector compliant remuneration package including numerous fringe benefits (luncheon vouchers, hospitalisation and ambulatory insurance, pension plan, etc.)
  • In addition to the fringe benefits received by all the personnel, you will also be provided with a company car.

Contact Details

Send your application (reference JOB169) now to Mrs Isabelle Lebrun, Talent Acquisition Manager, to recrutement@quality-assistance.be or consult the Careers page on our website http://www.quality-assistance.com/careers/jobs.

Address: Technoparc de Thudinie 2, 6536 Donstiennes, Belgium