QA Senior Associate

Orion Group Life Sciences are currently recruiting a QA Senior Associate on behalf of our Multinational Biopharmaceutical client based in Dun Laoghaire on an initial 12-month contract (with potential to extend).

The Plant Quality Assurance (PQA) Snr Associate will report to the QA Manager and will be a core member of the site Quality Assurance team. The PQA Snr Associate will serve as Quality point of contact for manufacturing operations.

The site is focused on continuous improvement of all work processes and practices, therefore in addition to routine Quality Assurance duties, PQA Snr Associates may be asked to carry out additional work functions to support site continuous improvement activities.

This is a 24/7 shift role required to support manufacturing operations.

Primary Responsibilities:

• Perform all activities in compliance with safety standards and SOPs.
• Write, review, and approve Standard Operating Procedures in accordance with Policies.
• Provide Quality support for triage and investigation of all classes of non-conformance (NC) events.
• Review and approval of deviations for closure ensuring compliance with appropriate documentation.
• Participates in customer complaint investigations.
• Provides training and advice to staff in order for them to perform their desired functions.
• Observe and provide real-time quality oversight, and support for production unit operations, extending to formulation, vial and Syringe Fill Finish related activities, including observation and provision of direction during media fills and assessment of aseptic interventions.
• Review/approve production batch records, and associated documentation in preparation for Qualified Person disposition activities.
• Review and approve cGMP records ensuring compliance with appropriate documentation.
• Support continuous improvement and Operational Excellence initiatives.
• Any other tasks/projects assigned as per manager's request.

Basic Qualifications:

• University degree. Engineering or Science related discipline preferred.
• Relevant experience (4 yrs +) working in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the requirements of the role.

Preferred Qualifications:

• Excellent written and verbal communication skills.
• Experience working with dynamic cross-functional teams and proven abilities in decision making.
• Strong organizational skills, including ability to follow assignments through to completion.
• Demonstrated ability in problem solving and experience in managing Root Cause Analysis /Deviation investigations.
• Experience working in aseptic operations, protein formulation, vial, and syringe filling.
• Knowledge of applicable Regulatory requirements, and ability to evaluate compliance issues.
• Experience working in aseptic operations, protein formulation, vial, and syringe filling.

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.