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If you care differently, you belong here.
Mission
To support the maintenance, development and continuous improvement of the Almirall GVP Quality Management System ensuring compliance with applicable regulations and guidelines.
Responsibilities
1. To support the QA GVP Senior manager in maintaining 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 cooperate in the setting up of the GVP risk-based audit plan and program and in performing (or coordinating and overseeing when outsourced) audits on a regular basis.
3. To report the audit observations arising from audits (or any other quality issue) to applicable management and follow-up on the significant findings until completion.
4. To help in the preparation and management of inspection by Competent Authorities and audits by third parties to Almirall by developing an inspection readiness plan.
5. To drat the procedures applicable to QA Drug Safety and any other key documents ensuring that they are aligned and compliant with the applicable regulation.
6. To contribute in selecting, coordinating and overseeing the outsourced QA activities applicable to pharmacovigilance (e.g. audits, mock inspections, training).
9. To support the Pharmacovigilance audits to the Almirall Pharmacovigilance system including processes, partners and CROs at both corporate and affiliate level.
Education
Life Sciences degree
Specific expertise
- Knowledge of drug safety, data management, and statistics.
- Awareness of EU and non-EU regulations applicable to pharmacovigilance.
- Training in Quality Assurance, specifically R&D areas.
- Proficiency in English language
CENTRO: R&D - Sant Feliu de LLobregat
TIPO DE CONTRATO: Temporal
GRUPO PROFESIONAL: 6
HORARIO: Central Flex
QA R&D & CPD - GVP Quality Assurance Specialist
