Les Quality Business Analyst - Wavre, België - GSK

GSK

Geverifieerd bedrijf

Wavre, België

2 weken geleden

Geplaatst door:

Sophie Dubois

beBee Recruiter

Beschrijving

Site Name:
USA - North Carolina - Zebulon, Belgium-Wavre, UK - London, UK - Surrey - Weybridge, USA - North Carolina - North Carolina Central, USA - North Carolina - North Carolina West, USA - North Carolina - Pinehurst, USA - North Carolina - Raleigh, USA - North Carolina - Raleigh East, USA - North Carolina - Raleigh West, USA - North Carolina - Rocky Mount, USA - North Carolina - Wake Forest, USA - North Carolina - Winston Salem, USA - Pennsylvania - Pennsylvania Central

Posted Date:
May

Job Description

As LES Quality Business Analyst, you will be responsible for providing technical analysis and development of solutions to support manufacturing processes.

You will also be responsible for overseeing the matrix environment working with various departments within the manufacturing organization.

This role will provide YOU the opportunity to lead key activities to progress YOUR career.

These responsibilities include some of the following:

Train site laboratory SME's on the static data requirement gathering process in data workshops and as needed throughout the LES product lifecycle (for example, product testing requirements, stability requirements and environmental monitoring requirements).
Facilitate harmonization of static data requirements across sites and products throughout the lifecycle of the product in LES. This may involve negotiating agreement of global ways of working, conflict resolution/escalation and business change.
Review static data requirements to ensure they have been completed correctly and align with LES data strategy and Analytical Data Governance standards and are right first time.
Review M-ERP data extracts, Empower and simple/complex instrument output to ensure they align with static data requirements.
Attend tech developer demos (with site SME's) to ensure the data is being built according to the static data requirements and data quality rules and strategy.
Work with sites and Tech developers to monitor and resolve data quality issues.
Review defects raised during data verification and assist with the RCA and CAPA resolution.
Identify risks and work with Tech and users to find and implement mitigations.
Review and approve data requirements and data change controls.
Ensure that the data configuration satisfies quality and regulatory requirements.

Why you?:

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

Bachelor's degree or certification in scientific discipline (Computer Science, Chemistry/automation, Data Management or other related Sciences).

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

Bachelor of Science or equivalence (Computer Science, Chemistry/automation, Data Management or other related Sciences).
Experience in pharmaceutical GMP laboratory testing activities
Experience in implementation and management of IT and automated equipment.
Experience in Data management, Data Governance and reporting / analytics.
Five or more years of experience working in a GMP Laboratory.
Excellent interpersonal skills, including the ability to work across the organization and interact/influence/negotiate effectively at all levels of management and peers.
Ability to analyze complex data/information/scenarios and make rational, riskbased decisions which are communicated and/or escalated clearly and confidently.
Ability to work well under pressure with tight timelines.
Must be flexible, adaptable and a strong team player.
Ability to travel and work independently.
Six Sigma and Lean Manufacturing experience; Black Belt or Green Belt desirable.

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 organization where people can thrive.

Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.

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 after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead 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 whe