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QA Operations Manager, Benelux
Il y a 4 mois
**QA Operations Manager, Benelux**:
- Zaventem, Belgium
- Quality
- 515407-gsknch
**Job Description**:
**Site Name**: Zaventem Da Vincilaan
- **Posted Date**: Jul 27 2023
- **
QA Operations Manager, Benelux**
Hello. We’re Haleon. A new world-leading consumer health company. Shaped by all who join us. Together, we’re improving everyday health for billions of people. By growing and innovating our global portfolio of category-leading brands - including Sensodyne, Parodontax, Aquafresh, Panadol, Advil, Voltaren, Otrivin, and Centrum - through a unique combination of deep human understanding and trusted science. What’s more, we’re achieving it in a company that we’re in control of. In an environment that we’re co-creating. And a culture that’s uniquely ours. Care to join us. It isn’t a question.
**Location**:Important information regarding the place of work**: Haleon Belgium will be moving into a brand-new office in Q3 2023 as part of our strategy to be more central by getting closer to Brussels and to evolve in a dynamic business environment. Located in the Zaventem well-known Corporate Village, Haleon aims to offer a more inspiring workplace where our people can benefit from many on-site facilities. But until then, we continue to operate from Wavre (Southern Brussels).
**Job Purpose**:
- The job holder will be member of the QA team within the Haleon Benelux Local Operating Company (LOC).
- Ensure Benelux LOCs and contractors are operating in compliance with EU/National regulations (GMP/GDP/MDR/EU Cosmetics, BE/NL/LUX regulations) and Haleon Quality System
- Supervision of **QA Operational activities **related to** distribution and batch release of Haleon products** in Benelux (*includes medicinal products, medical devices, cosmetics, food products and general consumer goods).
- Endorse QP delegate and RP responsibilities for Benelux Market(s).
- Support QA system activities and participate as Subject Matter Expert to the design, implementation, and maintenance of the** Benelux Quality Management System.**
**Key Responsibilities**:
- ** Qualified Person delegate (GMP / batch certification) and Responsible Person (GDP) responsibilities.**:
- ** With the Benelux Quality Lead, ensure compliance, product quality, **audit/inspection management and readiness
- ** Oversight and supervise** (guide/support when needed) the Benelux QA Specialists in the operational activities:
- ** Batch Release dossier preparation**:
- **Receipt, Storage and Returns**:
- **Local Repacking**:
- ** Quality Complaints management**
When relevant approve GxP related records (repacking acceptance form, returns)
- ** As QP delegate, participate to the QP-certification of medicinal products**:
- Ensure oversight of Benelux **Logistic Service Providers (LSP)** and participate to their qualification (**audit**, **Quality Agreement, licences/authorization review)**:
- ** Act as liaison with Haleon manufacturing sites and Contract Manufacturing Organizations** (CMO) to ensure manufacturing in compliance to local registered technical details. Participate with the Quality Lead to the **supplier qualification** activity and the review and approval of the **Technical Terms of Supply (TTS) and Quality Agreements.**:
- Ensure an efficient customer verification process is in place
- Approve and follow up Benelux **Change Controls**:
- ** Perform local review of annual Periodic Product Reviews (PPR’s).**:
- Participate to the setup of **Distribution Risk Assessments** (DRA) for products supplied from the local warehouse to the end customers.
- ** Ensure oversight and support Independent Business Monitoring (IBM) and Self-Inspections (SI),** in full compliance with GSK QMS, GMP/GDP-requirements and medical devices regulation.
- Ensure local Quality **deviation investigation (Root Cause Analysis), CAPA definition** and execution. Follow up the deviation and CAPA lead-times.
- ** Recall & Incident management**:Member of the local Product incident review Committee as appropriate and support of recall coordination when required.
- Support the QA team with the development and **maintenance of procedures and work instructions**.
- Act as **Subject Matter Expert** for specific Benelux GxP-processes and systems.
- Participate to Quality Councils. Support management reviews and KPI-reporting.
- Contribute to the Benelux Quality Plan (setup and execution).
**Qualifications and Skills**
- Master in Pharmaceutical Sciences or another related science.
- Good understanding of GDP and GMP, pharmaceutical regulation
- Min. 6 years of experience in the pharmaceutical industry, in a quality function.
- Certified Industrial Pharmacist / Qualified Person.
- 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
