As Change Control Coordinator, you manage projects and change control processes (eCC) for projects and changes planned in production units.
You coordinate and operate associated validation activities (Validation plan, installation qualification, operational qualification and performance qualification).
Your responsibilities :
You are responsible for initiation, implementation, monitoring and closure of projects / eCC linked to the LVV Primary facilities and / or to transversal activities / projects
You ensure implementation of the validation policies for the processes & equipment (Validation life-cyle process, Qualifications, Process Validation) with the coaching of your manager or colleagues.
You are responsible for participating, for change control sections, in external authorities inspections (EMEA, FDA, WHO ) with the support of your manager
You are responsible for assuring inspection readiness regarding Change Management (eCC) by Corporate GSK functions and Regulatory Affairs authorities (FDA, EMEA, Canada)
You act as a key interlocutor in your discipline between the MPU and other services (Technical Services / Validation / Purchasing / TLCM / QA / RA)
You act as the MPU representative in transversal and / or technical projects.
You continuously anticipate potential improvements of current processes with assuring the compliance with existing standards.
Basic Qualifications :
We are looking for professionals with these required skills to achieve our goals :
University degree in Engineer in Chemistry, biochemistry, or agronomy or Pharmacist
Knowledge of International standards (CFR and Eudralex), GMP and Regulatory
Good organizational skills
Proven ability to work cross-functional teams and projects to obtain desired business objectives
Good analytical and problem-solving skills
Strong communication skills. Proven ability to communicate effectively with different departments
Good knowledge in English, including presenting and negotiating.
Preferred Qualifications :
If you have the following characteristics, it would be a plus :
First experience in aseptic processing, vaccine production, quality control or quality assurance
Experience in a matrix organization
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