Specialist Quality Primary Validation - BPE

仕事内容

Site Name: Belgium-Wavre
Posted Date: Jul 25 2021

The Quality Assurance Primary Validation Specialist is part of the QA Operations for one Manufacturing Performance Unit.

You ensure the QA oversight of the continuous validation activities for one vaccine bulk production unit.

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 (ECC)
• To analyze the impact of automation modifications on the validated status
• To write and implement some validation documentation (VP, VSR, Risk Assessment, Gap Analysis, Periodic review)
• 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
  
  

Your Responsibilities

In this role you,

• 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, PQ, PV, VSR, PVMP, PQMP, PR, Annual assessment) 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)
• Ensure timely escalation to Management of critical issues during validation and/or project
• 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
• Attend all project meetings as QA expert
• Support from a compliance point of view the Manufacturing Performance Unit 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 Manufacturing Performance Unit Product & Process, Production and QA Operations
• Ensure implementation of validation related commitments towards internal and external authorities and organize the follow-up.
  
  

Why you?

Basic Qualifications

We are looking for professionals with the following required skills to achieve our goals (must-have):

• Scientific university degree (Pharmacist, Engineer or equivalent)
• Minimum 2 years of experience in a Pharmaceutical/Bio/Medical device environment or equivalent
• QA validation role with a close interaction with QA computer system validation - knowledge in computer system validation and/or in automation
• Very good knowledge of English
• Knowledge of GMP regulated environment experience
• A knowledge of different regulations and standards related to validation activities
• Maintain and keep up to date its knowledge and experience necessary to the function,
• Be a good team player in order to success in each validation project
• Problem solving and achievement oriented
• 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 continuously 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
  
  

Preferred Qualifications

The following characteristics are assets (nice-to-have):

• Good interpersonal relationship skills

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Why GSK?

Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork in a culture of Innovation, Performance and Trust.

Our Vaccines business has a broad portfolio and innovative pipeline of vaccines to protect people of all ages. We deliver over two million vaccine doses per day to people living in over 160 countries.

For further information, please visit www.gsk.com.

Our Department

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.

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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