Specialist QA Validation Projects PA/IPV
GlaxoSmithKline
- Waver, Waals Brabant
- Vast
- Voltijds
- Drive the QA Validation oversight for projects and some routine activities, as part of the GSK Vaccines network through the application of key business and GMP processes in line with the strategies, policies and standards of GSK Vaccines
- Built a strong partnership with the MU stakeholders in Validation/Process, Projects and external partners outside MU (central and global functions)
- Ensure regulatory compliance and audit readiness of the MU in scope and defend the validation approaches and decisions during internal and external audits with Validation partners
- Be the dedicated quality partner for validation activities
- Participate in validation planning and project meetings
- Participate to the definition of the validation strategy for various projects
- Review and Approve validation documentation (projects and routine) in a timely manner
- Ensure adequate oversight of validation activities on the floor
- Participate to and challenge investigations related to the validation activities
- Be an active participant of the process and technical improvements in the unit, and simplifications
- Ensure timely escalation to Management of critical issues during validation, or impacting the validated status
- Pro-actively identify potential quality and compliance risks and manage these risks trough the project meetings and escalation process
- Ensure QA representation and decision making in all meetings related to his/her area of responsibility
- Acts as front-line spokesperson or QA representation during inspections/audits for validation activities
- Ensure compliance with GSK Vaccines standards policies, procedures and local regulations
- University degree (Biotechnology, Agronomy, Chemistry, Pharmacy or Engineer)
- At least 5 years professional experience in pharmaceutical environment, in quality and validation environment
- Good oral and written communication skills
- French is mandatory
- Good Knowledge of GMP Regulated environment related to validation activities.
- Good interpersonal relationship skills
- Problem solving and solution-oriented mindset
- Agility to adapt to various projects/equipment/environments
- Good oral and written communication skills in English
- A knowledge of different regulations and standards related to validation activities
- To be a good team player in order to success in each validation project
- Able to take decision under pressure conditions
- Good knowledge of equipment processes
- Proactive and ready to take the lead to make things happen
- Ability to work under pressure on multiple deliverables within project time lines