Coordinator QA Validation

Job description

Details:
Job purpose :

The QA Validation Coordinator is part of the QA Operations for one MPU. He/She ensures the QA oversight of the continuous validation activities for one or several production units within one MPU.

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).

This job is highly specialized in the technical domain of validation but requires also a lot of interaction with numerous partners across the organization and many others quality systems. Therefore it requires a good understanding of the organization and interactions within the company.

Key responsabilities :

The responsibilities of the QA Validation Coordinator 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, PV, VSR, PVMP, RA, GA) documentation according to the GSK Vaccines 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.

1. Problem solving and innovation:
The QA Validation Coordinator 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.
- Develop and continuous improve expertises linked to the validation activities : expert on the field, technical and regulatory watch over.
- Be a strong advocate for validation approaches and activities during internal and external audits

2. The function requires:
- a knowledge of good practices in biopharmaceuticals,
- a knowledge of different regulations and standards related to validation activities,
- to maintain and keep up to date its knowledge and experience necessary to the function,

3. Nature of interactions :
The QA Validation Coordinator must be able to:
-Blow a quality and compliance mindset through the validation activities
-Develop and continuous improve expertises linked with global and corporate expertise functions
-Be a strong advocate for validation approaches and activities during internal and external audits

4. The function requires:
- to be a good team player in order to success in each validation project.

5. Impact:
This role operates at the MPU level. The QA Validation Coordinator by being accountable of the validation strategy to apply within each MPU projects can highly impact the resources:
-in terms of people involved in the validation project
-in terms of equipment usage during validation project
-in terms of production batches used for validation studies
-in terms of operational expenses related to the validation studies

Our Offer:

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.

The department:

Once our pioneering treatments have been developed, they are manufactured to the highest standards and distributed across the regions that need them most. Accomplishing this as efficiently and quickly as possible can quite literally be a matter of life and death. So it's no wonder that more than 70% of our talented workforce is based within Global Industrial Operations - the essential business unit that manufactures and manages the entire vaccine supply process, from customer order to product dispatch on a global scale.
As the name suggests, it operates in a multi-national context across more than 17 sites around the world, working closely in tandem with colleagues from a variety of disciplines and professions.
The department is structured in operating units that focus on various aspects of the manufacturing and supply process. These include Industrialisation (overseeing the transfer of production from R&D to a commercial level), Supply Chain Management and Technical Services.

Our Company:

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.

Contact information:
You may apply for this position online by selecting the Apply now button.

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Desired profile

Basic qualifications:
• Scientific university degree (Pharmacist, Engineer or equivalent)
• Minimum 2 years of experience in a pharmaceutical/Bio/Medical device environment or equivalent

Preferred qualifications:
• Very good knowledge of English
• Knowledge of GMP regulated environment