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Job Description
Quality Specialist sought to oversee distribution of pharmaceutical products in Dublin 12, ensuring compliance with Good Distribution Practice and Health Products Regulatory Authority guidelines.
Force Recruitment is partnered with a growing Irish Pharmaceutical distribution company to recruit a Quality Specialist on a Full Time, Permanent basis.
Responsibilities:
- Develop, implement, and maintain the Quality Management System.
- Ensure quality processes are understood and implemented through continuous staff training.
- Oversee procurement and supply of authorised products from approved suppliers and customers.
- Assist in approving outsourced services, route qualifications, and maintain Quality Technical Agreements.
- Review, draft, and approve documentation (SOPs, deviations, change controls, etc.).
- Perform Bona Fide checks on suppliers and customers, and maintain a risk management culture.
- Manage product returns, temperature-controlled shipments, and escalate issues like Adverse Reactions (ADRs) or product defects.
- Coordinate product recalls and act as deputy Responsible Person (d RP) in the absence of the RP.
- Ensure continuity of supply without compromising product quality, safety, or compliance.
- Escalate falsified medicines and ensure quality records are accurate within the Quality Management System.
Requirements:
- 3+ years QA experience in a Pharmaceutical or HPRA/FDA/EU & GMP/GDP regulated environment.
- RP Qualification is preferred but support will be provided to gain this qualification if necessary.
- Thorough knowledge of temperature-controlled activities.
- Thorough knowledge of c GMPs/GDPs and global regulatory requirements.
- Solid understanding of pharmaceutical WDA business models, especially with regards to quality and regulatory requirements.
Benefits:
- Health insurance
- Allowance
- Pension
- Life Assurance
- 23 Days Annual Leave (including good Friday)
- 4 Wellness days per year (1 per quarter)