Quality Specialist - Leinster - Life Science Recruitment

Life Science Recruitment Leinster

1 day ago

Description

We are seeking a skilled professional to join our team at Pharmaceutical organization in Louth. This role offers an excellent opportunity for those interested in project work and making a tangible impact.

Main Responsibilities

Manage event management systems, including review and approval of events and deviations.
Design and approve batch records, ensuring compliance with regulatory requirements.
Coordinate site change control systems, ensuring minimal disruptions to operations.
Develop and compile validation protocols and reports, covering analytical, cleaning, computer, process, equipment, and other areas.
Review and approve standard operating procedures (SOPs), work instructions, and forms from other departments on behalf of Quality Assurance.
Prepare for regulatory and customer Good Manufacturing Practice (GMP) inspections, ensuring site readiness and compliance.

Qualifications & Experience

Bachelor's Degree in a scientific or technical discipline is required.
Proven experience in quality within the biological and/or pharmaceutical industry is essential.
Familiarity with FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals is necessary. Ability to apply GMP regulations and international guidelines to all aspects of the position.

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