Specialist QA – Product Quality Review – GSK – Waver

Site Name: Belgium-Wavre
Posted Date: Sep 30 2021

Are you energized by a quality assurance role that allows you to accelerate compliance in a state of the art manufacturing environment? If so, this Specailist QA, Product Quality Review role could be an ideal opportunity to explore.

As a Specialist QA, Product Quality Review, you will be responsible for verifying the consistency of the existing manufacturing process, the appropriateness of current specifications highlighting any trends and identifying product and process improvements.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:

• You will be responsible for the writing of Product Quality Reviews for several product families according to cGMP requirements and in line with GSK standards. This includes qualification on data extraction, data analysis, sections and summaries writing.
• You will lead consolidation meetings with production, operational QA, QA release, QC, TLCM leader to bring all experts in agreement with PQR content.
• You will be fronter in audits/inspections to present PQRs under your product responsibilities and answer any question auditor/inspector may have.
• You are responsible to report any concern arising from the PQR exercise to management according to escalation process.
• You will take an active role in Company priority projects including -but not limited to- digitalization and automation initiatives, supporting the launch of products on the Chinese market, meeting requirements of Q agreements with other partners from a Product Quality Review perspective.
• You will be training and coaching stakeholders on the PQR process.
• You will closely work with PQR LSME to seek continuous improvement of the system including -but not limited to- according to GPS master plan.
• In case of CAPA/deviation, you will be responsible to investigate potential root cause and to ensure appropriate actions follow up.

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

• University Degree: Master degree in Sciences / Engineering e.g. Pharmacist / Master in Sciences / Bio Engineer (or equivalent by experience).
• Quality-oriented mindset.
• At least 5 years of experience in cGMP environment.
• Fluent in French and English (spoken and written).
• Good analytical skills, ability to summarize data and present them as a continuous story.
• Ability to meet deadlines.
• Exposure to audits and inspections.
• Strong team spirit.
• SAP

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

• Knowledge of pharmaceutical, aseptic and biotech processes.
• Autonomous, Rigorous, Structured, Systematic.
• Ability to lead cross-functional discussions.
• Experience with digitalization/automation.

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. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:

• Operating at pace and agile decision-making – using evidence and applying judgement to balance pace, rigour and risk.
• Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
• Continuously looking for opportunities to learn, build skills and share learning.
• Sustaining energy and well-being.
• Building strong relationships and collaboration, honest and open conversations.
• Budgeting and cost-consciousness.

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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