• Ensure Quality Management Systems are fully Compliant with Customer, Regulatory, Legislative and Business requirements.
• Execution of Quality Management System process controls within the Organisation and that of Sub-Contract Service providers.
• Provision of Administration support while maintaining the QMS (Quality Management System) in Compliance to Regulatory Standards in line with IS EN ISO 9001:2015 and EU GDP 2013C 343/01.
• Review and Approval of Standard Operating Procedure Documentation.
• Overall Responsibility for Record Management, Deviations, CAPAs.
• Responsible for leading Change Control and Continual Improvement Programs.
• Review and Implement Risk Management Plans with defined Actions and Targets.
• Manage Temperature Control and Transportation Validation Programs.
• Manage change in Regulation Controls and implementation of all such changes.
• Responsibility and Participation of Regulator and Customer Quality Inspections.
• Oversight of Master Training Plan in line with Regulatory requirements.
• Oversight of Internal and External Audit Plan within in Operations and Key Sub-Contract Service Providers.
• Liaise with Key Account Customers in Terms of Quality Performance and defining Quality expectations in terms of Service provision.
• Manage Quality Management System Targets in terms of KPI’s relative to Performance of Quality within key Department Functions.
• Preparation of Agenda, Review, Presentation of Quality Management Meetings.
Skills / Experience:
• A 3rd Level Degree in a relevant Scientific Role or related discipline essential.
• A minimum of 3 Years Work experience within a Quality or Compliance Role.
• Experience in Shipping / Logistics preferable.
• Strong Administration background with High level of Written and Verbal communication skills.
• The ability to Work on own initiative and as part of a Regional Quality Team.
Skills / Experience / Additional:
• Knowledge of ACSP (Air Cargo Security Program) desirable
• Knowledge of GDP (Good Distribution Practice) desirable
• Reporting to the General Manager - Managing Director.
• Liaison with Operations, Logistics and Sales Management
• Liaison with Customer Quality and Logistics Management Teams.
• Induction Training provided.
• Full Clean Driving Licence required.
• Qualification to IS EN ISO 9001:2015 Standard may be considered an advantage.
• Certified Training in GDP to RP / Deputy RP desirable.
• Approved Competency in Air Cargo Security Program Training desirable.
• Experience of Working within the Pharmaceutical or Medical Device Industry may be considered an advantage.
• The Position may require a flexible approach to Working Hours as required.
• The Position will be based at the Schiphol Facility.
• Salary commensurate with position
• Private Health Insurance
• Pension Scheme