Validation Lead

il y a 1 mois

Wavre, Belgique GSK Temps plein

**Site Name**: Belgium-Wavre
**Posted Date**: Nov 13 2024
**Job Purpose**:
To provide quality oversight to support implementation and maintenance of strategic computerised systems such that they are validated and operated in accordance with company and regulatory requirements. Provide consulting and inspection support to users.

We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme.

We embrace modern work practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work.

Discover more about our company wide benefits and life at GSK on our webpage _Life at GSK | GSK_

**Key Responsibilities**:
In this role you will:

- Fulfil the Quality Assurance responsibilities in the preparation and approval of Computer System validation records or manage the process in accordance with relevant procedures (e.g., Quality Management System).
- Provide input to the validation planning of high cost, complex, strategic systems using risk-based approaches to ensure systems are fit for purpose, that significant risks are identified and mitigated, and that the approach and rigor of validation is in proportion to the risks the systems present to regulated business processes.
- Provide and/or facilitate quality assurance oversight for the automation of business processes related to pharmaceutical manufacture, laboratory and distribution.
- Identify, resolve, and avoid project problems, typically involving ongoing interaction with management teams within Tech functions, Site and Local Operating Company Quality organizations, and Third Party suppliers/service providers.
- Participate in the deployment, maintenance, and inspection support of multiple global projects with responsibility for developing solutions that maintain compliance and keep validation on schedule and within budget.
- Ensure that issues and risks are identified, mitigated, and/or escalated for matters that could adversely impact quality compliance associated with projects and systems, while providing performance measures to drive performance and continuous improvement.

**Why you?**:
Basic Qualifications & Skills:
We are looking for professionals with these required skills to achieve our goals:

- Understanding of pharmaceutical manufacturing and distribution regulations, guidelines, principles and expectations.
- Broad experience in independently providing validation, deployment, change management, and inspection support of large, complex, computerised systems.
- Experience as an effective communicator with ability to collaborate and form strong partnerships within teams and diverse stakeholders/customers that result in "win-win" outcomes to achieve business goals and objectives.
- Fluently speaking French and English.

Preferred Qualifications & Skills:
If you have the following characteristics, it would be a plus:

- B.S. or advanced degree in Computer Science, Engineering, Pharmacology or related sciences.
- Technical knowledge to support quality and validation decision making for GxP analytical, manufacturing, distribution and IT computerised systems.
- Demonstrated ability to handle multiple priorities and complete work within agreed timescales e.g. key QA role deliverables.
- Demonstrated ability to successfully manage support to regulatory inspections including specific queries of computer systems validation/compliance activities and documentation.

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.

**Why GSK?**

**Uniting science, technology and talent to get ahead of disease together.**

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. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

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 place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look afte

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