Compliance Specialist

As compliance specialist for the Belgium Engineering and Maintenance Department, you will give support to the BeEM teams to comply with Quality requirements in terms of quality objectives:

• Help in the day-to-day management of unplanned events to respect the business targets,
• Give support to the teams to conduct effective and qualitative investigations on quality issues and set appropriate definition of CAPA’s,
• Coach the self-inspectors to ensure effective self-inspection process.
• You will help the technicians/managers in the documentation of unplanned events/CAPA in SAP to allow a high quality of the content and a state to the art in deviation/CAPA processes.

Your responsibilities:

• As delegate of the CAPA Deviation champion, you will support the deviation champion in his day to day work to:

• assure the overall quality and effectiveness of the deviation and CAPA process within BeEM
• ensure that best practices are in place and in use, seek for continuous improvement, while ensuring application of the right level (risk-based approach) of quality.
• assure capabilities buildup within BeEM (including QA) through effective coaching, monitoring/reporting, and performance management.
• be the back-up of DCC for CAPA committee and DRB.
• reports to the DCC the local issues and risks related to the CAPA and deviation process, requirements for improvement, or proposal for best practices.

• To support for Self-inspections, you will coach the self-inspector during audits.
• You will act as validation representative for BeEM equipments.
• For BeEM teams for which higher support is necessary, your roles will be:

• Lead root cause investigation and impact assessment;
• Write CAPA or/and deviations in SAP .
• Support the operational team to ensure the following of GMP / EHS tasks (CAPA / deviation / change control / audit)

• You will give support to the LSPOC inspection (be list key users, scribe or coordinator, help the BeEM teams to prepare inspection and response)

Why you?

Basic Qualifications:

• University degree: Pharmaceutical Science, Bio or chemical engineering, technical engineering or related field
• 2 to 3 years of experience.
• Ideally, has already manage CAPA and deviations
• Ideally, has already participated to Lean actions, or organization project.

Preferred Qualifications:

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

• Experience in people coaching
• Analytical, organizational, communication and interpersonal skills
• Fluent in spoken and written English
• Pedagogue, very good interpersonal capabilities, to be able to act as a coach.
• Facts and data oriented
• Technical background in automation, maintenance, validation, project management is a plus.

• Li-GSK

Why GSK?

At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Healthcare, strengthening our leadership, and transforming our commercial execution. Now, we’re making the most significant changes we’ve made to our business in over 20 years.

We’re on track to separate and create two new companies in 2022: New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and genetics science; and a new world-leading consumer healthcare company of loved and trusted brands. With new ambition comes new purpose.

For New GSK, this is to unite science, talent, and technology to get ahead of disease together – all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; and as a new GSK where outstanding people thrive. Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culture that is ambitious for patients – so we deliver what matters better and faster; accountable for impact – with clear ownership of goals and support to succeed; and where we do the right thing. So, if you’re ready to improve the lives of billions, join us at this exciting moment in our journey.

Join our challenge 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.

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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