Quality & Compliance Specialist
Our client, a global pharmaceutical company, are currently recruiting for a Quality, Compliance & Pharmacovigilance Specialist to join the local commercial affiliate office. The candidate will be responsible to manage all Quality, Pharmacovigilance and Compliance to ensure the affiliate is in compliance with all regulatory and legal requirements.
- Develop, manage and optimise the local Quality Management System to ensure compliance with corporate, regulatory and legal requirements
- Management of complaints, recalls/mock recalls, deviations, returns, change control for the local affiliate and ensure compliance with Good Distribution Practice requirements
- Perform local product release
- Oversee and manage the supply of product to Malta
- Pharmacovigilance – perform role of Local Safety Officer for the affiliate and ensure timely compliance with legal reporting requirements
- Perform periodic self-inspections when required.
- Management of Technical Agreements and Safety Data Exchange Agreements
- Act as Compliance Champion for the local affiliate – oversight of compliance within the company in terms of the company Code of Conduct and relevant local advertising regulations
- Perform the role of Privacy Champion, providing guidance and ensuring that the local affiliate is in compliance with the EU’s General Data Protection Regulation.
- Responsible for documentation, archiving and records retention
- Back up for medical information and regulatory affairs
- Prepare and deliver training materials for internal and external training on PV, quality and compliance topics
- Work collaboratively with relevant Global and country teams to establish and implement quality and compliance strategies within agreed timescales
- Advise the local teams on matters of compliance and quality, when required.
• BSc degree science or related field
• 4 years plus experience in a quality/compliance/regulatory affairs environment
• Knowledge of quality management systems and EU regulations for the pharmaceutical industry
• Effective project management, time management, organisation and prioritisation skills
• Excellent verbal and written communication skills
• Occasional travel may be required.
If you are interested in applying for this role please call Linda on +353 1 2784671 or email firstname.lastname@example.org
Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. www.thornshaw.com