Job Description
The Quality Assurance Manager is a leadership position is part of the Quality Systems group within the Technical Operations organisation based in Dublin. This position leads a team in Quality Systems to meet the global requirements for Product Quality Complaints, Vendor Management, Deviations and CAPAs and Change Control.
Responsibilities:
Responsible for developing and maintaining Quality Systems and Vendor Management activities to ensure that all operations are fully in compliance with current international standards for GMP and GDP.
Achieves company goals and objectives by recruiting, orienting, and training team members; develops personal growth opportunities for the team; achieves compliance by communicating job expectations; planning, monitoring, and appraising performance
Manage the GxP vendor qualification program including initial and ongoing qualification to ensure quality oversight of GxP vendors
Act as a lead auditor in third-party vendor audits, including GMP contract manufacturing, analytical testing and storage/distribution facilities
Manage the Quality Technical Agreement (QTA) process
Be a key member in the inspection team for the customer and regulatory inspections, including the inspection readiness process
Manage the process and compliance of the Pharmaceutical Quality System (PQS) as per ICH Q10, including Product Quality Complaints, Change Control, Deviation and CAPAs and Vendor Management
Contribute to the development of Quality policies and procedures with respect to the PQS
Design and implement quality metrics to assess the compliance of the PQS; to identify areas of improvement and support associated initiatives
To operate a process of continuous improvement and Operational Excellence within Quality Systems
Work directly with other key departments to ensure compliance and productive working relationships.
Work closely with other members of the Technical Operations organisation to ensure delivery of key project objectives and timelines
Contribute to the management of the supplier approval program through audit participation and GDP compliance oversight
Assist with troubleshooting quality issues at partner sites, when required.
Supporting regulatory submissions to ensure impacted licenses are maintained in compliance
Personal Competencies:
Bachelor's degree in. chemistry, biology or a related discipline
Experience working in finished product pharmaceutical/ biologics, including analytical chemistry, quality assurance, quality control, development, and /or manufacturing areas
Experience with third-party vendor auditing, complaint handling and change control
Thorough understanding of quality systems and GMP/GDP
Very good oral and written communication skills
Interpersonal skills and professional skills to interact at all levels including senior executives, contractors, and colleagues
Experience working with contract manufacturing
Lead auditor training and experience
Experience interfacing with regulatory bodies or supporting regulatory submissions
For further information on this QA Manager Systems/Leadership position please contact Laurentina Kennedy at The RFT Group on 01 2302400 / Laurentina@rftgroup.ie. Check out all our open jobs on our Recruitment website: www.rftgroup.ie
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