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Our purpose is simple: to transform patients’ lives by addressing real needs. We work with care, act with courage, keep things simple and focus our innovation where it makes a difference.
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If you care differently, you belong here.
Mission
Responsible for the maintenance, development and continuous improvement of the Almirall GVP Quality Management System ensuring compliance with applicable regulations and guidelines.
Functions and responsibilities
1. To maintain the Quality System for Pharmacovigilance activities in accordance with Almirall policies, ICH guidelines, EU GVP modules, and other relevant regulatory requirements with the support of the Almirall Corporate Patient Safety department.
2. To set up the GVP risk-based audit plan and program and perform (or coordinate and oversee when outsourced) audits at affiliates, partners, CROs/vendors as well as internal audits to the Almirall Pharmacovigilance System on a regular basis.
3. To report the observations arising from audits (or any other quality issue) to applicable management and follow-up on the significant findings until completion.
4. To lead the preparation and management of inspection by Competent Authorities and audits by third parties to Almirall by developing an inspection readiness plan.
5. To edit, review and approve the procedures and any other key documents ensuring that they are aligned and compliant with the applicable regulation applicable to Drug Safety.
6. To select, coordinate and oversee the outsourced QA activities applicable to pharmacovigilance (e.g. audits, mock inspections, training).
7. Involvement in due diligence of development products, as needed.
8. To promote the continuous improvement of the GVP Quality System based on audit findings and changes in regulatory requirements.
Education
Life science degree (Pharmacy, Chemistry, Biology, etc.)
Specific expertise
- Knowledge of GVP's, GMP's and GCP's, drug safety, clinical trials, data management, pharmacokinetics, and statistics.
- EU and non-EU regulations applicable to pharmacovigilance.
- Training in Quality Assurance, specifically R&D areas.
- Proficiency in English language
INFORMACIÓN ADICIONAL
- CENTRO DE TRABAJO: R&D - SANT FELIU DE LLOBREGAT
- TIPO DE CONTRATO: Indefinido
QA R&D & CPD - GVP Quality Assurance Senior Manager
