Quality Executive
Responsibilities:
• Support LOC Quality Manager on all QMS activities and Quality issues relating to the commercial Cx business and assist in heightening QMS knowledge and awareness of the LOC functional teams.
• Assist LOC Quality Manager in maintaining a robust, sustainable and effective QMS (Quality Management System) through ensuring the in place and in use of the processes rolled out in the the LOC for full compliance with GSK standards and policies, Guide for Commercial Companies, GMP, GDP and regulatory requirements.
• Assist LOC Quality Manager in executing a and maintaining a robust Quality Governance process encompassing the LOC Quality Council, Change Control, Risk Management, Corrective and Preventative Actions (CAPA) Management, Auditing system which is in line with GSK Internal Control Framework.
• Manage day-to-day complaints and product incidents and maintaining the effectiveness of the processes for incident escalation and product quality management, including associated systems or processes that are use to support these processes.
• Perform day-to-day activities that support product quality assurance during distribution and continued product supply in the market through controlled distribution, qualified testing and timely release of products with robust quality contractual agreements established with third parties and supplying sites which comply with the local regulations and GSK QMS, including timely resolution of Quality-related issues when arise.
• Undertake day-to-day support for repacking requests ensuring regulatory and QA compliance, timely QA batch release of repacked orders before distribution and/or re-export. Ensure as appropriate documentation of batch records and retention of samples. Provide artwork management process consultation to relevant business functions.
• Deputise for the LOC quality manager team in LOC during his/ her absence.
• Maintain all quality documentation such as product specifications and Standard Operating Procedures in accordance with GSK policies and current registered details.
Requirements:
•Bachelor’s degree, science or pharmacy preferred
•Minimum 6 years experience within QA
•Possess good knowledge, understanding of and experience in quality assurance systems particularly in the areas of batch release, product incidents, artwork control and performing audits
•Knowledge of regulatory requirements pertaining to GMP/GDP
•Knowledge on effective quality documentation systems
•Professional written and verbal English communication skills
•Ability to deliver clear communications and foster excellent working relationships with peers and management
•Analytical mind, good attention to detail and problem solving skills within a structured process
•Good team player – works well in cross-functional teams
•Ability to multi-task and work under pressure
•Flexible thinking – able to challenge and see views from different perspectives
•Ability to self-motivate and be resilient and focused under pressure
Pharmacist preferred
GSK Korea (제약법인) position 입니다.
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