Project Manager Validation

Job content

Site Name: Belgium-Wavre

Posted Date: Jul 28 2022

The purpose of the role is to apply the GSK validation methodology to the manufacturing activities in the bulk production building.

Your Responsibilities

• Responsible for the coordination of validation linked to HAV facility / process and small projects linked to change controls related to equipment, systems such autoclaves, …or CIP, SIP, Mediabulk, or utilities (EDI, EPI, EUF, VP, ACP).
• Responsible for defining and implementing an adequate validation strategy in compliance with FDA, EMEA and International quality standards.
• Project Management: control/monitor planning of all validation activities linked to HAV project (Microsoft project follow up) and Take corrective actions if necessary.
• Responsible for ensuring and coordinating the support (planning, weekly validation, resources, cost) to change controls or projects.
• Write and/or Review the validation documentation regarding the GMP requirements and the GSK Vaccines procedures (Protocols, Reports, Validation Plan, Validation Summary Report, Risk Assessment, Gap Analysis , Periodic review ….).
• Manage deviations and out of specifications: bring expertise and help in investigating and solving issues and associated CAPA.
• Ensure correct and state of the art Validation approaches for change controls from Design Qualification step to the establishment of the Validation Summary report (which is final approved by the QA). This accountability involves knowledge of the Validation Life-cycle process as well as in Specific Validation Strategies (i.e.Cleaning Validation, Aseptic Media Simulation…).
• Participate as expert in external authorities inspections (EMEA, FDA, WHO…).
• Responsible for assuring inspection readiness – regarding Validation – by Corporate GSK functions and RA authorities (FDE,EMEA,Canada).
• Has developed at least one area of expertise and is recognized as such.
• Bring expertise and coaching to streams.
• Ensure coordination with all key players (local QA, Global QA, C&M, Streams rep,…).
• Ensure the compliance on EHS topics in/outside his area and develop the EHS mindset within his team and peers.
  

Why you?

Basic Qualifications

We are looking for professionals with these required skills to achieve our goals:

• University degree: master degree in Sciences/Engineering e.g. Pharmacist / Master in Sciences / Bio Engineer pharmaceutical
• Minimum 5 years in the Pharmaceutical/Biotech industry with significant experience of GMP
• French fluent and professional writing and speaking in English are a must.
• Preferred knowledge of vaccines and/or immunology process and products (manufacturing).
  

Preferred Qualifications

If you have the following characteristics, it would be a plus:

• Expertise in validation, knowledge of International standards (CFR and Eudralex), GMP and Regulatory
• Experience in Project Management
• Successful experience in people management
• Good knowledge in RA and prior approval establishment RA inspections is an asset.
• Leadership, decision making, critical thinking and analysis of issues, impact and influence, innovative thinking, engage people, achieving excellence
• Manages own time to meet agreed short-term targets
• Ensures the coherence between contributions / quality of final results and procedures, encourages reflection on the need to adapt/align procedures; may propose new operating procedures
  

Why GSK?

Our values and expectationsare at the heart of everything we do and form an important part of our culture.

As GSK Focuses On Our Values And Expectations And a Culture Of Innovation, Performance, And Trust, The Successful Candidate Will Demonstrate The Following Capabilities

These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork.

• Agile and distributed decision-making – using evidence and applying judgement to balance pace, rigour and risk
• Managing individual and team performance.
• Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
• Implementing change initiatives and leading change.
• Sustaining energy and well-being, building resilience in teams.
• Continuously looking for opportunities to learn, build skills and share learning both internally and externally.
• Developing people and building a talent pipeline.
• Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation.
• Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally.
• Budgeting and forecasting, commercial and financial acumen.
• Li-GSK
  

If you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what specific assistance you require in order to make suitable arrangements.

Our goal is to be one of the world’s most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing.

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