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RP Quality Assurance Officer

Job description

Responsible for quality & safety assurance by supervising and coordinating management programs and systems to ensure that the products meet the highest quality standards.

QA

  • Determines the tactical and operational direction/priorities (in conjunction with line management) for the continuous improvement of the Site/BU QA management program and systems.
  • Responsible Person for the company
  • Agrees Quality agreements with external partners (contract manufacturers, logistic service providers and distributors)
  • Supports in ensuring ongoing inspection readiness in the areas of responsibilities.
  • Support the internal and external audits
  • Investigates quality incidents, deviations and complaints, identify and follow-up CAPA’s and supplier improvement plans together with contract manufacturers. and ensure all documentation is updated.
  • Evaluates and follow-up change controls as per company procedure
  • Develops the Quality Communication Strategy for all levels of staff, to include written information, tool box talks and management briefs.
  • Supports the maintenance of the Quality Management system as a SME.
  • Writes Product Quality reviews.
  • Part of Supplier Qualification and regular Supplier Auditing
  • Assists with integration of new product introductions
  • Assists in retaining all current quality accreditations and work towards the attainment of new quality accreditations.
  • Provides support and expertise to line management in incident investigation and reporting (including dangerous occurrences and occupational diseases).
  • Monitors the Site “permit-to-work” system to ensure compliance with standards.
  • Identifies gaps and areas for improvement in QA processes and handling/leading remedial actions and initiatives
  • Ensures effective training programs have been implemented.
  • Keeps a going awareness of new and developing regulations related to GDP’s and GMP’s.

Advise

  • Advises, assists and pro-actively coaches line management with the implementation of new or existing QA-related legislation, rules and Company standards.
  • Advises line management on Site of safety, quality and environmental matters and manages this process to ensure all advice is incorporated into day to day processes and operations. 

Safety

  • Actively promotes a safe working environment for all employees, through leadership by example, installing a culture of zero tolerance and discipline against breaches of the policies, and this throughout all ranks in the organization

 

 

Skills and personality

SKILLS AND PERSONALITY

  • Master (in pharmaceutical sciences, engineering, biochemistry, chemistry,…) or equivalent through professional experience
  • At least 5 years of relevant experience in QA in the pharmaceutical industry
  • Good knowledge of the relevant European regulations for manufacturing and distribution of pharmaceutical products
  • Strong project management skills
  • Speaks and writes fluently English. Other languages are an asset.
  • Self-starter, capable of working autonomously
  • Clear communicator, practical and solution orientated
  • Change management skills
  • Balancing entrepreneurial spirit with structure – willingness to adapt to shifting or competing priorities
  • Drive for performance (fast decision taking, positive, courage, curious, connected)
  • Empower people, look for alignment, teamwork, priority setting, trust, open communication
  • Seeks feedback to enhance performance
  • Efficiency and effectiveness
  • Regular international travel is part of the role.

 

Contract

Executive search

Experience

minimum 5 years

Education

Master's Degree

Languages

Sector

Pharmaceutical industry

Region

Brussels

Job type

Full-time

 
 

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