Qp/rp
Il y a 2 mois
**Salary**:
£50 - £100 per hour**Job type**:
Interim/Contract
**Location**:
Brussels, Belgium
**Function**:
Quality Assurance, QP
**Posted**:29/03/2023
**Ref**:
BBBH21904
- Hi I'm
Ingrid
, I manage this role
Hobson Prior are seeking a QP/RP to join a brilliant organisation on a contract basis.
Please note that to be considered for this role you must have the right to work in this location.
**Key Responsibilities**:
- Maintain compliance with regulatory requirements and adhere to the established Quality Management System.
- Distribution of medical devices should be ensured.
- In charge of batch release, storage, distribution, secondary packaging, and labelling.
- Assist Health Authorities with all quality-related issues.
- Responsible for handling and evaluating complaints regarding product quality, FMD alerts, and supply complaints (local complaints).
- Responsible for local recalls, including product security (major quality/safety issues).
- Responsible for QA agreements with local third-party service providers (e.g., archiving).
- Responsible for ensuring compliance with GMP/GDP guidelines and applicable pharmaceutical laws.
- Editing and updating GMP/GDP procedures.
- Coordinating external inspections/audits.
- Developing a self-inspection plan for the year.
- Providing input and signing off on Quality Assurance Agreements.
- Oversee Pharma Logistics, Ops Logistics / Quality Assurance (monthly quality meetings, approval of GQA audit).
- Accountability and official approval for "return" decisions.
- Review and approve changes initiated by the Product List
- Manage changes and compliance with the RA department (e.g., product launches, and withdrawals).
- Ensure customer qualification (on creation and annual verification)
- Developing the QAA with the sponsor and signing it.
- Audit the site to ensure compliance.
- Ensure batch records are reviewed and approved
- Make sure that IMPs are certified.
**Key Skills**:
- Dutch, French, and English understanding is required.
- Understanding of GMP/GDP regulations and guidelines applicable to pharmaceuticals.
- An understanding of computerized quality systems.
**Requirements**:
- Pharmaceutical industry experience in quality assurance.
- An industrial pharmacist (nominated QP).
- Competence in risk assessment is essential.
- The ability to understand pharmaceutical operations, including compounding (solids, liquids, creams, sterile, etc.).
- Leadership and facilitation experience in quality risk assessments.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.
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