Accountabilities
• Quality System Implementation & Management
• Resolution of Product Quality and Compliance Related Issues
– Manage and communicate all Product Quality, Pharmacovigilance and Compliance Related Issues that arise in Korea (coordinating with Global Affiliate Leader, supported by Regional Quality Leader)
– Deviation Management: leads/ supports/ implements and follows up agreed Zoetis action to address product quality/compliance issues identified when product is in the market place. Executes recalls and stop distributions.
• Support Inspections and Internal Audits
– Leads (participates) local Agencies Inspections in the Affiliate on Product Quality & GMP/GDP aspects.
– Participates but not lead other Zoetis Internal Audits made by GMS audit group on Product & GMP/GDP aspects
• Development and Maintenance of Consistent Quality Culture
– Metrics quality performance and communicates to Zoetis Korea LT and Global/Regional Quality Lead
– Provides ongoing education on Quality to relevant Zoetis Korea functional groups
• Routine in Country Quality Activities
– QA Batch release: Release of product for the Local Market consistent with local regulations
– Assure temperature readings/filing from Dataloggers and excursions investigations
– Quality oversight of the Logistics Service Provider Warehouses, i.e. the validation of warehouse and cold store, shipping system qualification, repacking/relabeling operations, returns, Good Distribution Practice (GDP) standards implementation
– Assists Global Security with investigations on issues of theft, diversion, and counterfeiting
– Work closely with warehouse management to ensure that Zoetis Quality systems implemented properly
– Ensures implementation of all applicable Product Quality SOPs. Create, review, approve, maintain adequate procedures and controlled documents
– Monitors local quality and compliance environment to ensure regulatory expectations concerning product quality are met by adjusting/enhancing local systems and processes when required and informing country and above country stakeholders of changes/new requirements
– Conducts internal assessments to assess compliance with quality systems
– Maintains alignment between corporate quality systems and local requirements
SKILLS, KNOWLEDGE, QUALIFICATIONS AND EXPERIENCE
• Education: University or advanced degree in Pharmacology
• Experience: Experience in animal or pharmaceutical industry will be received a preference.
• License: Pharmacist required
• Language Skill: Native Korean, Moderate in reading & writing and fluent speaking in English
• Presentation: Moderate presentation and public speaking skills
• Social Skills: Good interpersonal relationships
• Business Mind: Goal and results oriented