infarAMA is currently looking for a

Qualified/Responsible Person (QP/RP)

Quality Assurance Officer or Junior QA Officer

About infarAMA

infarAMA is an independent consultancy company providing high standard professional expertise in global regulatory affairs, quality assurance, vigilance and translation services to the health care industry within Benelux. infarAMA is headquartered in Strombeek-Bever and has a brand-new subsidiary in Aarschot.

Key responsibilities

Your role as a QP/RP will be to contribute to the implementation and optimization of projects of the infarAMA customers. You will be responsible for a variation of aspects within their projects such as:

  • Accomplish QP/RP duties according to the applicable local and EU regulations (RD 14 Dec 2006 – GMP/GDP guidelines): manage and assure continuous improvement of the pharmaceutical quality management system (QMS) and handle quality complaints, rejects, reworks, returns, recalls, change control, deviations and CAPAs
  • Batch certification (QP) and release for sale (RP) as primary and back-up QP/RP
  • Perform GMP/GDP compliance gap analysis and interact with other departments
  • Participate in GMP/GDP/QMS self-inspections and external audits
  • Ensure inspection readiness and act as primary contact during Competent Authority inspections
  • QA liaison with contract manufacturing organizations or third party logistic providers

Key responsibilities

  • Support the Quality Assurance (QA) department
  • Prepare the administrative release of finished products (medicinal products/medical devices)
  • Follow-up on the implementation of new artwork
  • Evaluate the destination of returned products
  • Handle product complaints and deviations
  • Assist in activities related to final product release by the QP (review batch documentation)
  • Write and implement standard operating procedures according to customer specifications
  • Ensure compliance with all applicable GDP/GMP regulations
  • Prepare and provide adequate training regarding QA procedures to staff and contractors
  • Participate in self-inspections and audits
  • Prepare quality variation dossiers in cooperation with the Regulatory Affairs department
  • Manage the QA documentation

Required profile

  • 5 years of working experience in (non-)sterile manufacturing, packaging and labeling and supply chain is an asset
  • Industrial Pharmacist, FAMHP certified (RD 14/12/2006 art. 48/EU Dir. 2001/83/EC)
  • Knowledge of GMP/GDP/risk management
  • Learning attitude and continuous improvement mindset
  • Problem solving capabilities
  • Result driven, accurate (eagle eye for details)
  • Excellent organizational and planning skills
  • Team player
  • Customer oriented (good communicator and assertiveness)
  • Fluent in English and Dutch and/or French

Required profile

  • Scientific degree or relevant experience (Min. 2 years in a QA department – irrelevant for Junior Officer positions)
  • Fluent in English, Dutch and French with excellent oral and written communication skills
  • Strong knowledge of current software
  • Enthusiastic, meticulous, methodological, flexible and reliable
  • Able to work both independently and in teams

Offer

  • A varied job consisting in challenging multi-disciplinary tasks in a dynamic and growing environment
  • Competitive benefits and compensation packages
  • Workplace mainly in Strombeek-Bever

Offer

  • A varied job consisting in challenging multi-disciplinary tasks in a dynamic and growing environment
  • Competitive benefits and compensation packages
  • Workplace in Aarschot or in Strombeek-Bever

Applications

Interested? Send your resume and application letter to p.vandenweghe@infarama.be.

For more information, feel free to contact us.