Qa Specialist

2 weeks ago

Cork, Cork, Ireland Tandem Project Management Ltd. Full time

Summary:
A QA Specialist is required for a biopharmaceutical company in East Cork.
The successful candidate will be responsible for coordinating regulatory requests, managing Annual Product Quality Reviews, and supporting updates to site quality systems (including deviations, change controls, and Quality Risk Management).
The incumbent will also help drive improvements to QMS processes, and handle QA review and approval of deviations, change controls, and procedures.
Metric tracking and reporting are also part of the role.
Responsibilities: Participates within inter-departmental and cross-functional teams.Performs a variety of activities to ensure compliance with applicable cGxP regulatory requirements.Manages and co-ordinates Regulatory Requests submitted to the company.Authors Annual Quality Review site contributions and co-ordinates with global team.Assist with investigations and corrective and preventive action (CAPA) relating to quality systems.Performs metric gathering and critically assesses the data for emerging trends.Working directly with personnel to drive improvements to the QMS processes.Participates as a team member in projects related to the QMS processes and quality.Participates in authoring, reviewing and approving Standard Operating Procedures (SOPs)/ Deviations/Change Controls and other types of controlled documents.Performs walkthrough of departments on behalf of the QA department to ensure site compliance to GMP.Works on assignments that are routine in nature, where ability to recognize deviation from accepted practice is required.Exercises judgment within defined procedures and practices to determine appropriate action.Qualifications & Experience: Relevant degree.6+ years of relevant experience in a GMP environment.Prior experience in pharmaceutical industry (ideally within a QA role).Working knowledge of current Good Manufacturing Practices (cGMPs) (FDA / EMEA standards and quality systems).Demonstrates advanced working knowledge of QA systems principles, methods, QA concepts, industry practices and standards.Maintains and develops programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs).Proficiency in Microsoft Office applications.
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