Quality Systems Officer - Walloon Brabant
Keyrus Biopharma
4 dagen geleden

Job Description

As a Quality Systems Officer within Keyrus Biopharma, you will join a team on client's site to support the Quality System process owner in projects related to improvement, development and / or implementation of new Quality Systems processes and associated tools.

Scope :

General support in all projects related to Quality Systems improvement

Role and main tasks :

You will support the Quality System Process owner in the improvement, development and implementation of new Quality Systems processes :

  • Develop pragmatic & efficient fit-for-purpose processes that are aligned with stakeholder expectation, relevant external regulations (eg GMP, GCP, PV, GLP, ), and internal global policies and standards (QMS).
  • Ensure stakeholder management in order to engaged all relevant partners in the development phase as well as to ensure proper management of expectations.
  • If applicable, liaise with IT for tool development and / or customization
  • Develop process documentation (SOP & working instructions) and tools that are user-friendly, easily understandable, pragmatic & applicable, in alignment with applicable regulatory expectations and internal global policies and standards (QMS).
  • Develop communication strategy, including stakeholder management
  • Develop training strategy, including training material
  • Deploy process & training strategy
  • Build team capability during project by being a mentor to people involved in the project, in order to develop their skills and competencies and raise them to expert level.

    Education :

  • University degree or equivalent
  • Hard Skills :

  • In-depth knowledge of regulations (GMP, GCP, GLP, PV, ISO 9001, .)
  • Proven experience in process development, improvement and deployment
  • Strong and proven Quality System experience (eg for Deviation, CAPA, Change Control, training, documentation, escalation, risk, processes)
  • Mentoring proven capabilities, engaging and communicative personality
  • High negotiation, diplomacy and influencing skills. Able to interact with peers, subordinate and senior personnel in multidisciplinary environment.
  • Ability to lead the process to generate the exchange of ideas to resolve problems, prioritize solutions, select optimal solutions and implement decisions.
  • Fluent in English and French
  • IT Skills :
  • MS Office
  • Soft skills :

  • Willing to work on the shop floor to transmit experience
  • Team worker as most of its results depend on team engagement
  • Achiever, action oriented as immediate impact is expected
  • Good problem solving and communication skills.
  • Good communication skills.
  • Good analytical skills; ability to investigate and ask questions, on the shopfloor.
  • Autonomous, Rigorous, Structured, Systematic.
  • Ability to work in team, multidisciplinary environment; lead and impact cross-functional team members.
  • Team worker and lobbyist as most of its results depend on team engagement
  • What we offer

    You will receive a competitive based salary depending on your education and experience in an attractive package of extralegal benefits (company car, petrol card, meal vouchers, group insurance, hospitalization ).

    Each employee will be welcomed with a varied integration program. We invest considerable time and resources in training our staff (technical and non-

    technical courses). You will join a dynamic and international environment with enthusiastic and professional colleagues.

    Who we are

    Keyrus Biopharma is an international Consulting, Contract Research Organisation and Functional Services provider with a reputation for transparency and integrity, highly focused on being able to deliver with excellence.

    Our human’ approach to service provision is what differentiates us from our competitors. Combined with our high caliber staff, this approach has allowed us to become a key player in clinical research.

    At Keyrus Biopharma we’re proud of our commitment to delivering services of the highest quality, not only skillfully, efficiently and reliably, but also with sincerity and genuine care for our clients’ projects, priorities and reputation.

    Thus we maintain and advance our vision and our standards, all the while ensuring that we serve your interests better

    From early- to late-stage drug development, our range of services includes : Project Management, Clinical Operations, Pharmacovigilance, Quality Assurance (GxP), Regulatory Affairs Strategy & Support, Data Management, Medical Review & Coding, Biostatistics, Medical Writing & Medical Information, Real World evidence services.

    Keyrus Belgium Offices :

  • Office Park Waterloo - Drève Richelle 161 - 1410 Waterloo
  • Nijverheidslaan 3, - Strombeeck Bever
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