Type of contractContract, Permanent
Our client is specialized in the delivery of services and provision of solutions in the Life Sciences industry. With 20 years of experience, it supports its clients in the pharmaceutical, medical device, biotechnology, food and cosmetics industries.
Reporting to the Head of Program Management the GMP Change Control Expert is responsible for designing and owning a GMP compliant management and documentation of the Quality integration activities for integrating the legacy of a company into another. This includes designing an overarching GMP change control structure and supporting the Work stream and Project Leads in launching specific Change Controls for the integration.
Overall the GMP Change Control Expert is responsible to assure that the Quality Integration Program is delivered in an auditable format and that the requirements from GMP and other regulations are fulfilled.
The GMP Change Control Expert supports the Work stream and project leads in all aspect of designing a GMP compliant integration.
- Design, write, bring to approval, track execution and close-out of the GMP Change Control documentation
- Own the GMP oversight and documentation plan: build it and maintain it actual
- Assure GMP compliant management of all transition activities
- Assure GMP compliant and auditable documentation of the transition
- Support the Integration Project in the design and setup of the Change Controls specific to this integration activity
- Train the Project team on the requirement for GMP Change control
- Anticipate and participate to solving of issues; highlight best practices, promote continuous improvement and harmonization
- Support the project for the Integration of the Change Control Process
- Called in for advice on their respective subject both within and beyond the Integration
- Build capabilities by supporting and coaching Stakeholder for the Change Control process requirements for Integration
- Track activities defined in the GMP change controls
- Report Status of Change Control and actions to PMO
¨Level of Uncertainty: Highly complex and working across various matrix departments from R&D to GVCOE
(Global Vaccine Commercial Excellence Organisation) and GIO (Global Industrial Organisation) including various Business Operations department.
There will be a moderate degree of uncertainty in the operating environment because: 1) GMP regulatory expectations change overtime and need an appropriate risk-based level of interpretation;
¨Level of influence required: Ability to influence multiple stakeholders in matrix organization. The incumbent must have excellent communication skills to gain trust and support within the Global Functions and Users. The incumbent must lead and inspire a sizable Quality/Technical network.
¨Insight and problem solving: The incumbent will be required frequently to assess and review concepts and strategies, and to suggest corrective actions appropriately into the quality systems. The incumbent will be required to assess and review GMP related issues, to be a strategic analytical thinker, suggest corrective actions and appropriately escalate problems through various Governance committees when appropriate
- University degree preferably with a scientific orientation
- At least 5 year Experience in Quality, preferably with Quality Systems and GMP Change Control
- In depth expertise in change control process in European, US-FDA and Asian environment.
- In-depth knowledge of worldwide GMP regulations (CFR, Eudralex, WHO), guidelines and corporate policies.
- Extensive expertise of the manufacture and control for bulk viral/bacterial/polysaccharides vaccines
- Formulation, filling, packaging and distribution of final vaccine products.
- Skills in Technical Writing skills to issue official documents and coaching/training skills
- Affinity and skills to using Computerized Systems, specifically SAP
- Strong Communication Skills capability to influence and manage people and strong communication skills to ensure senior management are taking appropriate decisions
- Flexible and team work approach in a multi-cultural environment
- Demonstrate fluency in spoken and written English
- Organized, Rigorous, Reliable and Detail Oriented
- Experience in participation to complex multidisciplinary projects
- Knowledge of Manufacturing/Quality and GMP requirements
- Expert in training/coaching others to GMP practices.
- A position with responsibility within a leading international company
- Personal development through learning on the job and additional external trainings
- A market oriented compensation, including a range of fringe benefits
Job Reference: GMPchangecontrolexpert1
Salary per: Zero
Job Start Date: