Orion Group Life Sciences are currently recruiting a QA Specialist on behalf of our Multinational Biopharmaceutical Client based in Meath on an initial 6-Month contract with potential to extned.
Responsibilities:
Lead, facilitate and participate daily on cross-functional teams to collaboratively actively to address compliance issues and achieve project milestones.
Participate in investigations and risk assessments related to deviations/ complaints and changes, ensuring appropriate actions are implemented timely.
Provide QA review and approval of Change Controls, Deviations/CAPAs, SOPS and related documentation for compliance to GMP and site requirements at the facility.
Provide QA oversight to the Microbial and Analytical Method Validation, Analytical/ Microbial Technical Transfers, Regulatory approvals, Clinical and Commercial operations at the facility.
Support QA operational duties related to product disposition including the performance of detailed review of eBR prior to QP release and Material release.
Support an environment of continuous improvement by identifying and implementing efficiencies and quality improvements.
Participate in and support risk management activities in line with relevant guidance and best industry practice.
Work collaboratively to foster strong relationships with management and colleagues and to drive a safe and compliant culture.
Ensures the escalation of compliance risks to management in a timely manner
Qualifications:
Degree qualification (Science/Quality/Technical).
5-10 years' experience, ideally in Quality Assurance, Quality Control or Technical Operations within the Biological and/or pharmaceutical industry.
Project Manager capability with significant understanding of Operations.
Demonstrated experience in QRM, Investigations, Problem solving as a Quality SME.
Strong written and verbal communication skills.
Ability to think logically and be proactive under pressure.
Ability to work as part of a team and on own initiative in a constructive manner.
Strong attention to detail and precision in preparing and reviewing GMP documentation.
Experience in quality management systems such as Veeva, SAP, PAS-X etc.
Demonstrated knowledge and application of industrial regulations including those of FDA, HPRA, EMEA and other authorities related to Biologics and/or Pharmaceuticals.
Experience in direct interactions with regulatory agencies during site inspections.
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.
