Specialist QA

il y a 5 jours

Wavre, Belgique GSK Temps plein

**Site Name**: Belgium-Wavre

**Posted Date**: Jun 25 2024

**Job Purpose**:
An operational role responsible for the QA oversight of operations in his/her areas of responsibilities.
- Promote, master and ensure quality systems and cGMPs are in place in use.
- Responsible of quality decision regarding products/activities.
- Manage a team of Technician (not mandatory).

**Key Responsibilities**:

- Ensure the compliance on EHS topics in/outside his area and develop the EHS mindset within his team and peers.
- Ensure Quality Systems (deviation, OOS investigation, CAPA, documentation, training, change control, validation activities, maintenance and calibration activities) are in place in use and handled in a timely manner.
- Ensure with his/her team that release of Product Batch Record and/or QC Release Documentation is under control in his area responsibility.
- Ensure compliance of the operations with cGMP, Authorities and QMS requirements and escalate major quality issues and/or compliance gaps to management and relevant governing bodies.
- Proactively informed and involved with the requirements needed with improvements of current processes to ensure the compliance level is maintained in line with cGMP and GSK standard requirements.
- Act as QMS Subject Matter Expert (SME) and/or Single Point Of Contact (SPOC) on Quality Systems (knowledgeable of the QMS standard related to the area of expertise, ensure all requirements of the standards are in place within department, accountable for gap analysis and related action plans, active member of SME/SPOC communities of practices).
- Ensure the respect of L1 and L2 audit planning and report closed in a timely manner, potentially realize L1 and L2 audit - Supervise / Manage day to day QA activities (Operations, Technical Services, QC, Warehouse, Technical Services Support, Site Management) in an operational environment including multiple technologies and in his/her area of responsibility and ensure the relevant QA Oversight is in place (not mandatory if no team to manage).
- Supervise a team in keeping with operations needs and team capacities and capabilities, responsible to reallocate activities in the team if needed (not mandatory if no team to manage).
- Manage team performances through regular shopfloor presence, define action plans, ensure the implementation and measure through KPIs within his areas of responsibility (not mandatory in no team to manage).
- Evaluate skills and performances, defines and ensures regular follow-up of development plans of each team member (not mandatory if no team to manage).
- Manage complex technical and/or production problems, evaluate potential impact on product quality and escalate to management.
- Promote continuous improvement mindset in a day to day activities within his/her team and peers - Use Operational Excellence tools (e.g.: STP/IPO/PSS/Fishbone/5S ) on day to day activities.

**Why you?**:
Basic Qualifications:

- Pharmacist, Engineer, or equivalent.
- At least 5 years of experience as a QA Specialist.
- Strong level of spoken and written French.

**Preferred Qualifications**:

- 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.
- You have excellent communication skills.
- You are a team player.
- You are resilient and rigorous.

LI-GSK

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

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 to

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