GDP Quality Coordinator

• Act as the Single Point of Contact (SPOC) for Quality regarding deviations, returns, temperature excursions, incidents, and CAPAs.
• Initiate, manage, and maintain deviation records within the Veeva Quality Management System (QMS), ensuring timely investigation, documentation, and closure.
• Coordinate and follow up on investigations with internal stakeholders and third-party logistics providers (3PLs) as required.
• Plan, facilitate, and lead Root Cause Analysis (RCA) activities involving cross-functional teams and external partners.
• Collaborate with cross-functional teams to define, implement, and monitor Corrective and Preventive Actions (CAPAs) to ensure effective deviation resolution.
• Work closely with Operations, Quality Assurance (QA), the O2I Team, and external logistics partners to support timely incident and deviation management.
• Support the investigation and resolution of customer-related quality issues with a high level of accuracy and compliance.
• Maintain accurate records of deviations and temperature excursions in SharePoint.
• Monitor incident management activities in close collaboration with the O2I Team.
• Participate in regular governance meetings, including:
  
  • Weekly Distribution/QA meetings
  • Bi-monthly Operations Review meetings with 3PL partners
  • Monthly Business Review meetings with external logistics providers

Education & Experience

• Bachelor's degree or equivalent qualification in Pharmacy, Life Sciences, Chemistry, Supply Chain, or a related discipline.
• Minimum of 5-7 years of experience in the pharmaceutical industry, preferably in GDP, Quality Assurance, Quality Management, or Supply Chain.
• Solid understanding of Good Distribution Practice (GDP), deviation management, CAPA processes, and Root Cause Analysis methodologies.

Technical Skills

• Advanced knowledge of Veeva QMS.
• Good working knowledge of SAP.
• Proficient in Microsoft Office applications (Word, Excel, PowerPoint).
• Experience working with SharePoint.

Interested to support this project, during a peek phase?
Looking forward to your application