Quality Assurance, Quality Systems (BioTech, Limerick)

PRINCIPAL ASSOCIATE - QUALITY ASSURANCE, QUALITY SYSTEMS required by CareerWise Recruitment for our multinational BioTechnology client at their new facility in Limerick. This is a permanent role.

The PRINCIPAL ASSOCIATE - QUALITY ASSURANCE, QUALITY SYSTEMS will be involved in building state of the art, digitally enabled QMS and assure that the Quality System(s)/Program remains in a validated state and within regulatory commitments. Also provides Quality leadership, direction and governance for Limerick Change, Deviation Management, CAPA Business process incl. systems and compliance.

THE ROLE:

• Co-ordinates the site program to ensure compliance with the Global Quality Standards. Drives efficiencies in this process.
• Ownership of Change and Deviation Management System, ensures implementation to the site of same and that it aligns with Global Quality Standards
• Point of contact for generation of Notification to Management for exceptions to Global Standards
• Report & escalate critical quality issues to appropriate level of quality management for resolution
• Co-ordinate and report site compliance information and management review reports
• Works cross functionally to ensure site contribution to Site Compliance Report is completed and provide site context and additional analysis/information as required
• Working with Global Quality Systems group to ensure value-adding, right sized approach to Management Reviews and with QA Mgt to ensure management reviews are resourced appropriately
• Business Process owner for Change Management, Trending and Activity Planning
• Responsible owner of GMP documents/processes in relation to Change Control, Trend Analysis, Observation Management and GNP activity planning/tracking
• Review and approval of key GMP documents such as GMP standard operating procedures as appropriate to area of responsibility
• Responsibility for compliance with the Global Quality Systems & local procedures
• Interpretation and application of emerging Global Quality System changes, Regulatory & GMP guidelines to the specific Quality System(s)/Program
• Benchmarking of current and emerging initiatives in the specific Quality System(s)/Programs.
• Review and approval of change controls, deviations and failure investigations. Co-ordinates Root Cause Investigator facilitator group
• Communication and education of personnel in GMP requirements and regulations related to the area(s) of responsibility.
• Provide training oversight on the system of Global Quality Standards/Lilly Quality Standards
• Support site GMP inspections ensuring appropriate technical resources are identified to support inspections
• Generation and reporting metrics such as observation metrics, backlog metrics, change control metrics to senior management and for incorporation in to relevant site trending scorecards
• Participates in site deviation and change reviews

REQUIREMENTS:

• BSc, Msc, or PhD in Biotechnology, Chem, Eng or Science related discipline with appropriate experience
• Minimum of 5 years' experience in GMP operations.

Please call Conor Twomey today for further information on 087-0907204 or email: ctwomey@careerwise.ie

CareerWise Recruitment (In Search of Excellence)

Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors.

We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin.