Quality Manager and RP Deputy

Your Responsibilities:
The job holder will be member of the Quality team within GSK Pharmaceuticals Belux Local Operating Company (LOC) and will supervise the Belux Quality Operational activities related the distribution of GSK medicines according to GDP guidance including local administrative release, complaint handling, management of product returns and repacking activities. The jobholder will also act as deputy Responsible Person (RP) and provide support to the implementation and maintenance of the Quality Management System (QMS) to meet GSK compliance standards and local Regulator requirements

Key Responsibilities:
Supervision of Belux Quality Operational activities:
• Interact with GSK-sites and Contractors (CMO) to ensure compliance of manufactured products with local registered technical details (in collaboration with local regulatory team).
• Review and approval of the Technical Terms of Supply (TTS) and Quality Agreements where needed.
• Support Distribution Risk Assessments (DRA) for products supplied from manufacturing site to distribution centre and to the end customers.
• Ensure that any local Logistic Service Provider (LSP) is monitored, audited, and a Quality Agreement is in place and hold the required authorisations and certifications.
• Act as deputy Responsible Person (GDP) and perform local administrative release of medicinal products prior to the distribution on the market in line with the marketing authorization files.
• Support processes and systems for all activities related to goods receipt, storage, returns and market recall in compliance with GSK QMS.
• Supervise outsourced Repacking activities.
• Participate and manage Quality incidents related to distribution activities and support Recall & Local Incident management as appropriate.
• Support and/or perform Independent Business Monitoring (IBM) and Self-Inspections (SI), in full compliance with GSK QMS and GDP requirements
• Provide training to Belux associates where required in terms of basic GDP-requirements, and other Quality processes.
• Supervise the management of products returned from the market and approve any returns to saleable stock as RP deputy.
• Support the Quality team with the development and maintenance of local procedures and work instructions.
• Assist in Authority GDP inspection readiness process and provide support during audits and inspections of the Belux organization.
• Support and/or manage Change Controls by initiation, follow-up and action plan execution.
• Facilitate local deviation investigations (Root Cause Analysis) and CAPA determination and execution.
• Act as Subject Matter Expert for specific Belux processes and systems and interact with Global organization.
• Support management reviews and KPI-reporting and drive Quality improvement.

At GSK we value diversity and treat all candidates equally. We aim to create an inclusive workplace where all employees feel engaged, supportive of one another, and know their work makes an important contribution.
If you require a reasonable adjustment to the application/selection process to enable you to demonstrate your ability to perform the job requirements you will have the opportunity to let us know what specific assistance you require. This will help us to make suitable arrangements to support you throughout our selection process.

*LI-GSK

Why You?

Basic qualifications:
• Master degree in scientific disciplines such as Pharmaceutical sciences, Biology or Chemistry with minimum 4 years of experience in Pharmaceutical industry within relevant Quality functions.
• Strong general computer literacy with intermediate skills in Microsoft Word, Excel, Power Point and Outlook
• Able to work effectively in English, Dutch and/or French

Preferred qualifications:
• Analytical mind, good attention to detail and problem-solving skills within a structured process
• Knowledge of Regulatory requirements pertaining to GMP/GDP
• Professional written and verbal communication skill
• 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
• Flexible thinking, able to challenge and views from different perspectives

Why GSK?:
GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer.
We have 3 global businesses that research, develop and manufacture innovative pharmaceutical medicines, vaccines and consumer healthcare products.

Pharmaceuticals - Our Pharmaceutical business has a broad portfolio of innovative and established medicines. We currently focus on developing new medicines in respiratory and HIV/infectious diseases, oncology and immuno-inflammation; with discovery research exploring these and other areas.
For further information, please visit www.gsk.com.

At GSK we provide a supportive working environment, and a range of development challenges and opportunities. We also offer competitive benefits and compensation packages designed to attract and to retain the very best.

Contact information:
You may apply for this position online by selecting the Apply now button.
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