QA Specialist I

Orion Group are sourcing a QA Specialist on behalf of our Multinational Biopharmaceutical Client on an initial 12-month contract located in Cork.

This is a contract role for a QA Specialist, within the GSIUC QA Department under the QA packaging and labelling support team. The successful candidate will be required to perform QA approval and release of primary and secondary packaging components, QA review and approval of packaging and labelling documents, procedures, and GMP deviations. This position requires a sound knowledge of quality assurance systems, methods and procedures. The candidate will be required to exercise judgment within well-defined and established procedures and practices to identify problems and appropriate actions and to generate alternatives and recommendations within defined processes. The candidate must be proactive in their daily activities and interactions.

Key Responsibilities

• Performs a wide variety of activities to ensure compliance with applicable cGxP regulatory requirements.
• Participates in developing Standard Operating Procedures and writes and/or implements changes to controlled documents to ensure quality objectives are met.
• Participates in reviewing and approving Standard Operating Procedures (SOPs)/other types of controlled documents.
• Performs QA review and release of primary and secondary packaging components.
• May participate in QA review and approval of artwork.
• Identifies deviations from accepted practices, exercises judgement to evaluate impact and determines appropriate actions.
• QA Review and approval of GMP Deviation investigations and CAPAs.
• QA Review and approval of Master data and recipes required for operations.
• May participate in data gathering exercises, to develop and maintain QA metrics.
• Participate in compliance improvement projects involving cross functional teams.
• May assist with compliance audits and walkthroughs as required on behalf of the QA department to ensure site compliance to GMP.
• Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs).
• Normally receives very little instruction on routine work, general instructions on new assignments.

Education and Experience Requirements

• Prior experience in pharmaceutical industry is preferred (ideally within a QA role)
• Demonstrates proficiency in Good Manufacturing Practices (GMPs).
• Demonstrates proficiency in application of QA principles, concepts, industry practices and standards.
• Demonstrates working knowledge of FDA / EMEA standards and quality systems.
• Demonstrates basic knowledge of OPEX Lean tools and root cause analysis tools used for identifying and correcting deviations.
• Demonstrates audit and investigation skills, and report writing skills.
• Demonstrates good verbal, technical writing and interpersonal skills.
• Demonstrates proficiency in Microsoft Office applications.

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.