Specialist, QA
il y a 1 semaine
Site Name:
Belgium-Wavre
Posted Date:
Mar 7 2023
**_ Specialist QA Validation Technical Service
- Formulation_**:
This position is for you
This position will allow you to be part of the QA validation/ TS team in the vaccine formulation building (WN30).
Formulation is at the center of GSK's innovation strategy with the upcoming start of production of the RSV vaccine, MenACWY, Shingrix Full liquid and many others to come.
The building is a driving force for new product launches.The team is composed of 6 people whose objective is to ensure that the quality requirements, related to validation and technical services, are maintained for the production of vaccines.
Your role will be to ensure that projects meet cGMP requirements and that the validations in place remain aligned with these same requirements.
"WN30, a human, innovative and ambitious MPU, which aims for excellence every day, to be a competitive reference tomorrow."In this role you will
- Challenge, review and approve qualification and validation (URS, IQ, OQ, PQ, PV, equivalence certificate, requalification protocol/report, design qualification) documentation and ensure they are written in accordance with the GSK Vaccines standards and procedures
- Write some validation (VP, VSR, PVMP, PQMP, PR, Annual assessment) documentation according to the GSK standards and procedures
- Ensure adequate oversight and followup on the validation deviations both in terms of content (root cause and CAPA) and form.
- Ensure timely escalation to Management of critical issues during validation and/or project
- Proactively identify potential quality and compliance risks and manage these risks trough the risk registers and quality plan process
- Provide a compliance in the projects
- Attend all project meetings as QA expert
- Support from a compliance point of view the MPU Product & Process, Production and QA Operations for validation topics. Build a strong partnership with these key stakeholders
- Support the validation approach and decision during internal and external inspection and prepare the strategy of defense with MPU Product & Process, Production and QA Operations
- Ensure implementation of validation related commitments towards internal and external authorities and organize the followup.
As QA Technical Service, you'll be responsible to:
- perform oversight of technical services activities (maintenance, C&M, Master data, projects...)
- Ensure adequate oversight and followup on the TS deviations both in terms of content (root cause and CAPA) and form.
- Ensure timely escalation to Management of critical issues during routine maintenance and/or project
- Proactively identify potential quality and compliance risks and manage these risks trough the risk registers and quality plan process
- Provide a compliance on technical aspects in the projects
- Attend TS/project meetings as QA expert
- Support from a compliance point of view the Technical Service, Production and QA Operations for TS topics. Build a strong partnership with these key stakeholders
- Support the TS compliance approach and decision during internal and external inspection and prepare the strategy of defense with MPU TS, Production and QA Operations
- Ensure implementation of technical services related commitments towards internal and external authorities and organize the followup.
_ This job opportunity is a permanent contract __not_
_ opened for relocation. _
_Why you? _
Qualifications & Skills:
- University degree (Biotechnology, Agronomy, Chemistry or Pharmacy) or equivalent by experience.
- 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
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
_ Why GSK?_
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.
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