As a QA Specialist, you will be member of the QA team within the GSK Consumer Healthcare Benelux Local Operating Company (LOC). You will perform Benelux QA Operational activities such as complaint handling and batch release. You will provide support to the implementation and maintenance of the local Quality Management System.
Your responsibilities
- Assisting in the batch release process, ensuring on time release in compliance with regulatory and GxP-requirements.
- Evaluating product quality complaints. Managing complaint samples. Following-up and reviewing, the complaint investigations performed by the manufacturers.
- Performing complaint trending and reconciliations.
- Supporting in the maintenance of Quality Agreements with suppliers.
- Tracking and coordinating repacking activities.
- Assisting in the management of products returned from the market.
- Interacting with logistic service providers.
- Supporting the QA team with the development and maintenance of procedures and work instructions.
- Assisting in the GxP-inspection readiness process and providing support during audits and inspections of the Benelux organisation.
- Supporting the management of Change Controls by assisting in the initiation, follow-up and action plan execution of Change Controls.
- Supporting / facilitating local deviation investigations (Root Cause Analysis) and CAPA determination and execution. Recording and performing follow-up in TrackWise system.
- Acting as Subject Matter Expert for specific Benelux GxP-processes and systems (e.g. complaint handling).
- Assisting with Periodic Product Reviews (PPR).
- Management of quality documentation (retention, archiving).
Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
- Master in Pharmaceutical Sciences or another related science
- Quality experience in application of Quality Systems & Quality Operations
- Strong general computer literacy with Intermediate skills in Microsoft Word, Excel, Power Point and Outlook
- Able to work effectively in English, French and/or Dutch
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
- Analytical mind, good attention to detail and problem-solving skills within a structured process
- Good team player – works well in cross-functional teams
- Good time management skills, with ability to multi-task and work under pressure
- Works with a spirit of continuous improvement and innovation, creatively open to new ideas and methods
- Ability to self-motivate and be resilient and focused under pressure
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. 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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