Contracting – Brabant Wallon
If you want to know about the requirements for this role, read on for all the relevant information.
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.
Strong knowledge and proven experience in Quality Control and applicable regulations
Proven understanding of QC processes: stability studies, material management, specification management. xphnsxz
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
Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way. You're interested in this job? We kindly invite you to apply or send me your CV,
FDA, Auditing Activities, Audit, Business Needs, Documentation, KPI, Prioritize Workload, Stability Studies, SME, Compliance Audit, Product Management, Communication, Spot checks, Coaching, Validation, Audit Observations, Stakeholders, Projects, Inspection, Regulation, Investigations, Training, Product Reviews, Organization Skills, Coordination, Communication, VOS, Quality Control, Material Management, Leadership, Quality Reviews, EMEA, cGMP, Quality Control, Best Practices, Lean Tools, Management, Operations, Quality Control, Control Process, PIC, Change Control, D&O, Quality assurance, Process Quality, Internal Quality, Six Sigma