QA SPECIALIST

Almirall; Sant Feliu de Llobregat, Sant Andreu de la Barca; Presencial; EUR 42.000 - 62.000; A tiempo parcial

Descripción de la vacante

Almirall seeks a QA GVP Specialist to support maintenance and improvement of the Pharmacovigilance Quality System in line with ICH, EU GVP, and applicable regulations. The role involves audits, inspections readiness, and coordinating outsourced QA activities across corporate and affiliate levels.

Degree in Life Sciences with knowledge of pharmacovigilance regulations, data management, and statistics is required. Proficiency in English and IT systems is essential for success.

Formación

• Knowledge of drug safety, data management, and statistics.
• IT systems skills.
• Awareness of EU and non-EU regulations applicable to pharmacovigilance.
• Training in Quality Assurance, specifically R&D areas.
• Proficiency in English language.

Responsabilidades

• To support the QA GVP Senior manager in maintaining the Quality System for Pharmacovigilance activities.
• To cooperate in setting up the GVP risk-based audit plan and program and audits.
• To report audit observations to management and follow up on significant findings.
• To help prepare and manage inspections by Authorities and audits by third parties.
• To draft procedures for QA Drug Safety and key documents ensuring alignment with regulations.
• To coordinate outsourced QA activities for pharmacovigilance and training.

Conocimientos

Drug safety

Data management

Statistics

IT systems

Regulations (EU & non-EU)

English proficiency

Educación

Life Sciences degree

Descripción del empleo

## QA SPECIALISTApplyremote type: Industrial Operationslocations: SANT FELIU DE LLOBREGAT: SANT ANDREU DE LA BARCAtime type: Full timeposted on: Posted 3 Days Agotime left to apply: End Date: July 31, 2026 (20 days left to apply)job requisition id: 001568We’re building the future of medical dermatology by focusing on unmet patient needs and giving people the space to think independently, take ownership and make an impact that matters.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.Recognised as a Top Employer in Spain since 2008 and in Germany since 2025, we continue to invest in an environment where people can grow and move forward.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.- IT systems skills.- Awareness of EU and non-EU regulations applicable to pharmacovigilance.- Training in Quality Assurance, specifically R&D areas.- Proficiency in English languageCENTRO: R&D - Sant Feliu de LLobregatTIPO DE CONTRATO: TemporalGRUPO PROFESIONAL: 6HORARIO: Central FlexQA R&D & CPD - GVP Quality Assurance Specialist