QA for QC process H/F/X

Description de la fonction

Contracting - Brabant Wallon
GENERAL QA ROLE Using a Risk Based Approach, ensure that PSQC Processes & Operations are compliant with applicable regulations and guidelines (EMEA, FDA, PIC/S, ICH, best practices as defined by relevant organizations) and Policies & Procedures Drive quality leadership and provide technical expertise on compliance strategy. Communicate processes requirements effectively across functional areas. Promoting culture of quality, operational excellence and "SOSD" (See it, Own it, Solve it, Do it) attitude within Patient Supply Quality Control. Deliver general cGMP training and effective coaching on QMS to relevant stakeholders. Communicate compliance status and issues to appropriate organizational levels. Support regulatory inspections/audits, providing dynamic assistance to SME's. PATIENT SUPPLY QUALITY CONTROL PROCESSES Participate in the improvement of the PSQC processes Ensure adequate coaching and training of relevant stakeholders on the PSQC processes Oversee critical global activities to ensure analytical operations are conducted in accordance with Quality Standards and applicable national and/or international regulations and guidelines (EMEA, FDA, PIC/S, ICH) Manage and follow-up of Deviations, OOS, Failure Investigations, Change Control, Qualification/Validation, Compliance Audit activities, Stability program, Lab Critical Materials, and documentation approval related to the PSQC Processes & Operations. Ensure subcontractors supporting QC routine operations maintain adequate cGMP standards Implement and maintain adequate Quality & Compliance indicators and communicate results to appropriate levels of the organization CONTINUOUS IMPROVEMENT Identify, coordinate and support opportunities for improvement and operational excellence projects in response to business needs, technical changes, risks, audit observations and regulatory requirements. Lead or co-lead internal quality spot checks/audits to ensure compliance with internal standards and worldwide regulatory requirements with respect to cGMP. Conduct or support Quality Reviews exercises (e.g. Management/Product Reviews, etc) Identify, coordinate and support Continuous Improvement projects (LEAN, 6-Sigma, Green belt and others) with QC management to enhance quality KPI's and product/process quality.

Profil

Strong knowledge and proven experience in Quality Control and applicable regulations Proven understanding of QC processes: stability studies, material management, specification management. Experience with Quality Management System and Internal/External Auditing Ability to balance multiple priorities, projects, provide leadership and prioritization, and work with minimal supervision Excellent team player attitude with excellent interpersonal relationships and communication skills Fluent in French and English

Compétences linguistiques

• Français (atout)

  • Comprendre : Expérimenté - (C1)
  • Écrire : Expérimenté - (C1)
  • Lire : Expérimenté - (C1)
  • Parler : Expérimenté - (C1)

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