Job Title
Quality Operations Manager (hybrid)
RK23040
Contract – 11 months
Meath
We are currently recruiting for a key member of the quality team to ensure site operational compliance aligns with cGMP regulations. This position is responsible for maintaining cGMPs for assigned areas in conformance with policies and in compliance with cGMPs and Health Agency regulations.
The Quality Assurance Operations Specialist will provide quality support to the site, including training and guidance on company Guidelines / Policies and regulatory requirements as required.
Duties:
* Lead cross-functional teams 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.
* Provide QA oversight to qualification/validation, technical transfers, regulatory approvals and commercial/clinical operations.
* Complete QA operational duties related to product disposition including in-coming material release and detailed review of eBR prior to QP release.
* Evaluate new and prospective regulatory guidance and industry best practice and determine impact on Quality systems identifying and implementing appropriate updates where required.
* Assist in development of training curricula and records for the QA Operations Group providing SME training on Quality Assurance SOPs as required.
* Assist in creation and maintenance of QA policies, SOP's and reports in line with site requirements.
* 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.
* Assist in execution of the internal audit programme including performance of audits are required.
* Work collaboratively to foster strong relationships with management and colleagues and drive a safe and compliant culture.
* Ensure escalation of compliance risks to management in a timely manner.
Required Skills and Qualifications
• Degree qualification (Science/Quality/Technical).
• 8-10 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.
• Experience in quality management systems such as Veeva, SAP, PAS-X etc.
If interested in this posting please feel free to contact us for further information.