Temps Plein QA Validation Specialist
Description de L'emploi
Ville: Wavre WBR BE
– University (Master) degree in Sciences / Biological Engineering (e.g. Pharmacist / Master in Sciences / Bio Engineer)
– At least 5 or 8 years of experience in a pharmaceutical / biotech / medical device / food industry or equivalent environment as Manufacturer, Engineer, Validation expert or Quality Assurance
– Direct experience with GxP regulated environment within major authority jurisdiction (FDA / EU / WHO Audit)
– Successful team leadership experience
– Relevant quality experience or validation experience not necessarily within a quality department
– Experience with clean or aseptic would be appreciate
– Strong knowledge of cGMP and guidelines (FDA/EU/WHO)
– Good knowledge of different regulations and standards related to validation activities
– Ability to master the key QA activities related to production, QC, maintenance, calibration, and validation in the area of responsibility
– Strong interpersonal and people management skills with demonstrated engaging, empowering and decisive leadership style and well developed relation building skills to gain trust and credibility and to build a great place to work and good social climate
– Demonstrated impact and influence
– French speaker with good level of written and spoken English
Job purpose :
The QA Primary Validation Specialist is part of the QA Operations for one MPU.
He ensures the QA oversight of the continuous validation activities for one or several vaccine bulk production units.
Mains objectives of this function are:
– To take part in the establishment, the implementation, the follow-up and the maintenance of the continuous validation plan (CVP),
– To define the validation strategies through the change control process (RPC),
– To write and implement some validation documentation (VP, VSR, Risk Assessment, Gap Analysis),
– To review and approve specific qualification and validation documentation (IQ, OQ, PQ, PV),
– To ensure the correct application of the validation quality systems on the field and to define improvement plan as required,
– To support the production & technical services teams in the implementation of the validation activities,
– To ensure the adequate management of validation deviation (be QA GMP Responsible) and potentials CAPA (be Compliance Authority).
– To act as a SME (Subject Matter Expert) for one specific validation topic across Belgium sites
The QA Primary Validation Specialist objective implies the following commitments:
– To ensure an efficient and compliant CVP implementation
– To provide a compliance and business expertise for some specific technical subjects
– To act as a key person during both, internal and external inspection
Key responsabilities :
The responsibilities of the QA Primary Validation Specialist are among others:
– Challenge, review and approve qualification and validation (IQ, OQ, PQ, PV) documentation and ensure they are written in accordance with the GSK Vaccines standards and procedures.
– Write some validation (VP, PQ, PV, VSR, PVMP) documentation according to the GSK Bio standards and procedures.
– Ensure adequate oversight and follow-up on the validation deviations both in terms of content (root cause and CAPA).
– 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 follow-up.
– Participate to external audit as appropriate.
– Implement change initiatives involving processes, technologies and people which contribute to the overall effective improvement of Quality within the MPU.
– Apply lean sigma across the teams to ensure continuous improvement.
– Share and integrate best practices within the Vaccines Quality Network.
The QA Primary Validation Specialist must be able to:
– Understand quickly the characteristics and the mechanism of a broad range of production equipment and process including their potential impact on product and patient safety.
– Use a risk based approach for problem solving and prioritization of tasks
– Blow a quality and compliance mindset through the validation activities
– Develop and continuous improve expertise linked to the primary validation activities # expert on the field, technical and regulatory watch over, linked with global and corporate expertise functions
– Be a strong advocate for validation approaches and activities during internal and external audits
At GSK we provide a supportive working environment, and a range of development challenges and opportunities. We also offer competitive benefits and compensation packages designed to attract and to retain the very best. GSK is proud to promote an open culture, encouraging people to be themselves and giving their ideas a chance to flourish. GSK is an equal opportunity employer.
Global Quality Departments is responsible for setting up all global rules and regulations to ensure GSK vaccine products are manufactured, tested, released and distributed in compliance with regulatory requirements.
The QA Belgium departments manage all product quality related activities in industrial operations in Belgium, including regulatory compliance. The scope covers any action that potentially impacts final product quality. The QA Belgium department is also responsible for the release of final products made in Belgium and abroad.
Quality for Research & Development in partnership with R&D teams promotes quality and enables them ensuring activities of Research & Development are delivered in a compliant and sustainable way, in order to guarantee patient safety, company and regulators satisfaction, as well as successful product pipeline delivery.
GSK is one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.
GSK Vaccines is one of the world’s leading vaccine companies, with a comprehensive portfolio of 39 vaccines for infants, adolescents and adults and 15 more in development. We have more than 16,000 people working worldwide to deliver nearly 2 (1.9) million vaccines every day to people in around 90% (172) of the world’s countries.
For further information, please visit www.gsk.com.
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