QA Validation Specialist
il y a 3 semaines
**Site Name**: Belgium-Wavre
**Posted Date**: Mar 17 2023
**Specialist QA Validation & Technical Service - Filling department**:
You will ensure the respect of the Quality systems and processes linked to Validation and Technical Services (TS) activities for the Filling Department (WN16 building). This role is ideal for you if you're looking to work in an innovative and ambitious building which has a central role to play in meeting the site's objectives. You will be presented with several opportunities to collaborate with multidisciplinary teams, engage with teams directly on the shop floor and take the lead in ensuring quality and compliance.
**In this role you will **
- Challenge, review and approve qualification and validation documentation (URS, IQ, OQ, PQ, PV, equivalence certificate, requalification protocol/report, design qualification) and ensure they are written in accordance with the GSK Vaccines standards and procedures
- Write some validation documentation (VP, VSR, PVMP, PQMP, PR, Annual assessment) according to the GSK standards and procedures
- Ensure adequate oversight and follow-up on the validation and technical services deviations both in terms of content (root cause and CAPA) and form.
- Ensure timely escalation to Management of critical issues during validation, project or routine maintenance.
- Pro-actively identify potential quality and compliance risks and manage these risks trough the risk registers and quality plan process
- Provide a compliance in the projects (facilities - utilities - equipment - processes) in the MPU
- Attend all project meetings as QA expert and ensures QA decision making
- Support from a compliance point of view the MPU Product & Process, Production, Technical Service and QA Operations for validation or TS topics. Build a strong partnership with these key stakeholders
- Support the validation approach and TS compliance approach and decision during internal and external inspection and prepare the strategy of defense with MPU Product & Process, Production, Technical Service and QA Operations
- Ensure implementation of validation and technical services related commitments towards internal and external authorities and organize the follow-up.
- perform oversight of technical services activities (maintenance, C&M, Master data, projects...)
**_ This job opportunity is a permanent contract _**_not_**_ opened for relocation._**
**_ Why you? _**
- Qualifications & Skills:_
- University degree (Biotechnology, Agronomy, Chemistry or Pharmacy)
- At least 5 years professional experience in pharmaceutical environment.
- Good oral and written communication skills in French & English
- Good Knowledge of GMP Regulated environment related to validation activities
- Preferred Qualifications & Skills:_
- A knowledge of good practices in biopharmaceuticals
- A knowledge of different regulations and standards related to validation and/or TS activities
- To maintain and keep up to date its knowledge and experience necessary to the function,
- To be a good team player in order to success in each validation/TS project
- Good interpersonal relationship skills
- Problem solving and achievement oriented
- Able to take decision in stressing conditions
- Good knowledge of equipment and/or TS processes
- Proactive and ready to take the lead to make things happen
- 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.
GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.
**Important notice to Employment businesses/ Agencies
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