eFlexes Recruitment and Staffing Solutions have an exciting opportunity for an experienced QA Supervisor based with our multinational client in Pharma sector in Shannon, Co.Clare. It is a permanent contract role.
JOB PURPOSE:
Provide leadership, direction, and expertise with regards to all Quality & GxP/GMP Compliance activities at the site. Provide day to day leadership, direction, and support to the Quality Assurance. Acts as deputy to the Director of Quality as and when required.
PRINCIPAL ACCOUNTABILITIES:
Full oversight of site Quality Management System, including;
• Batch Release, Deviation Management, Auditing, Change Control, Complaints, GxP/GMP, CAPA System, Quality and Technical Agreements, Vendor approval, Product Quality Review
Risk Management
• Facilitation of cross functional teams in the performance of quality risk assessments
• Review and/or approval of completed Quality Risk Assessments
• Management of QRA’s as life cycle documents.
Operational Excellence
• Champions Operational Excellence culture within the QA team and leads/drives projects to support compliance and efficiency projects across the site from QA perspective
Project Management
• Delivery of site projects including system integration projects, support of new product introduction and associated compliance activities.
• Participate in Global compliance initiatives as requested.
Compliance
• Assist the Director of Quality in the management of regulatory inspections and corporate audits at the site and lead customer audits as required.
• Influence site personnel at all levels to develop/maintain compliance culture whilst championing a collaborative approach to achieving quality goals.
People management resposibilities
• The Supervisor is responsible for supervising and developing people within their team. This entails all people management aspects of the role.
QUALIFICATIONS:
• Must hold at least a Degree in Chemistry or another relevant science subject
• Must hold Internal Auditor Certification
EXPERIENCE:
The supervisor is required to have acquired the following experience;
• 5+ years’ experience working in a quality function within a GMP / regulated environment (ideally in the pharmaceutical / API).
• 3+ years at supervisory level.
• Experience in operational excellence, continuous improvement, lean, six-sigma, project management, would be an advantage.
• Experience in managing/presenting in regulatory inspections and customer audits is required.
KNOWLEDGE:
The supervisor is required to possess and demonstrate the following knowledge;
• Excellent knowledge of cGMP especially Quality Systems.
• Regulatory requirements for APIs and Pharmaceutical products
• Application of six sigma, quality risk management and project management.
• Knowledge of validation is desirable.
• High level computer proficient e.g. MS Word, Excel, Power-point, Quality Systems, SAP.
