Principal QA Associate

at  Life Science Recruitment

BASIC QUALIFICATIONS:

• BSc, Msc, or PhD in Biotechnology, Chem, Eng or Science related discipline with appropriate experience
• Minimum of 5 years’ experience in GMP operations
• Ability to influence without authority
• Demonstrated ability to lead and motivate in a team environment. Demonstrated ability to influence peers and across functions.
  For further information contact Alan on alan.oriordan@lifescience.ie / +353 87 365 7522

MAIN PURPOSE AND OBJECTIVES OF THE POSITION:

• 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.
• Provides Quality leadership, direction and governance for Limerick Change, Deviation Management, CAPA Business process incl. systems and compliance.
• Assures consistent implementation of standards across the quality system.
• Manages quality-related matters specific to quality systems & compliance.
• Is responsible for approving appropriate quality-related documents.
• Performs design and ongoing monitoring which includes but not limited to the following programs:
  1) Monitoring of quality systems,
  2) The self-inspection program
  3) Verification of the effective implementation of key GMP programs

4) Review of systems that impact safety, product quality to ensure that they operate in a state of control.

• Establishment, maintenance and management of a control system for and training of individuals in the specific Quality System and/or Quality Program assigned.
• Provide coaching and mentoring to other QA reps, to provide appropriate and timely solutions to compliance in a business focused fashion.

KEY RESPONSIBILITIES:

• 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/Company 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