LOC Quality Supervisor, Quality-LOC
Job Purpose 岗位目的:
Provides effective and efficient quality assurance support to the LOC Quality Manager, including supporting the implementation of the QMS and GSP in the products supply chain distribution. As directed by the LOC Quality Head performs the day to day work to ensure that the quality systems required by the LOC element of the Supply Chain and Marketing Company LOC are performed in a lean and efficient way and meet the compliance standards of the QMS and the local GSP relevant regulations.
1. Quality Strategy
• Maintain QMS knowledge and awareness of changes within the commercial environment to seek opportunities and manage potential business adversity.
• Act as the relevant LOC quality contact for customer complaint and investigation.
• Gain an understanding of the Supply Chain and Commercial LOC Business and Quality Plans at a high as they potentially link to day to day and quality improvement activities.
2. Quality Systems Implementation
• Supporting the LOC Quality Manager to ensure a robust, sustainable and effective QMS (Quality Management System) through monitoring and reviewing the compliance status within the LOC element of the Supply Chain and GSKCI Marketing Company.
• Support the implementation and maintenance of effective Quality Assurance systems to ensure that local operations are in full compliance with GSK standards and policies, Guide for Commercial Companies ,GMP, GSP and regulatory requirements by supporting the LOC Quality Manager as directed to:
o Ensure that all SOPs are in place, updated & training has been conducted across the business. Ensure a monitoring system in place for tracking training compliance and process for escalation of persistent non-compliance. Processes in place for delivering routine training for updates to SOPs, GQPs, and GQMPs as relevant.
o Promote QMS management principles and seek continuous improvement of the processes
o Review, conduct impact assessments and implement any updates to QMS policies
o Manage QMS Management Review meetings according to local SOPs
o Identify, Implement and Manage QA Objectives & KPIs
• To comply with GSP requirements and routine maintenance for the GSK CI operating procedures and records.
• Support the LOC Quality Manager to ensure that all internal procedures and systems in use in the LOC are compliant to GSK QMS, Guide for Commercial Companies and local regulatory requirements, including (but not limited to)
o LOC Quality Council - support the LOC Quality Manager re organizing Council meeting with regular meetings. This support should ensure that the LOC Quality Council format, frequency and reporting are standardised to global requirements. In addition support should be provided re Quality metrics and reporting format/ system in place.
o Risk Management - perform activities to support the risk management process to ensure effective management, timely reporting, review and escalation of quality risks. RMS system operation.
o Incident management - Support the LOC Quality Manager to ensure that an effective local product incident process is in place to escalate and manage any product quality related issues and in the training of all relevant staff in local incident management process and global PIRC process. Assist the LOC Quality Manager in any investigations triggered by local incidents and in conducting LOC Incident Committees.
o CAPA Management- ensure CAPAs generated by different quality systems are maintained through well controlled and monitored manager, ensure escalating appropriately and on time.
o SAP System "CERPS" Quality Module operation for Deviation, CAPA, Change Control, Customer Complaint.
o Product supply - performs day to day work to support systems that have an impact on the quality of imported, products in line with the QMS and local Regulatory requirements
• Liaison with External Supply Quality for products that are manufactured by contractors to ensure compliance to local registered technical details.
• Ensure timely local Quality release of imported finished goods deliveries and resolve Quality-related issues arising from these deliveries.
• Support the LOC Quality Director with communication to the GMS supplying sites, R&D and Regional Quality as it relates resolving Quality issues with the product supplied
Education and Experience:
• Successful completion of relevant tertiary qualifications - science degree or equivalent
• 2-5 years experience within the Pharmaceutical / Consumer Healthcare industries, preferably in the capacity of a quality specialist or a supervisor
• Understanding of and experience in quality assurance systems particularly in the areas of batch release, product incidents, artwork control and performing audits
• Good knowledge of regulatory requirements pertaining to GMP/GDP
• Good knowledge on effective quality documentation systems
Essential Skills and Abilities:
• Good written communication skills. Able to deliver positive and proactive communications and foster excellent working relationships with stakeholders at GMS organization
• Ability to influence and motivate stakeholders at any level of the LOC organization
• Analytical mind, good attention to detail and problem solving skills within a structured process
• Good team player - works well in cross-functional teams
• Good time management skills, with ability to multi-task and work under pressure
• Concise and persuasive in the description of the different QA situations. Able to stick to the standard and not be pressurized.
• Works with a spirit of continuous improvement and innovation, creatively open to new ideas and methods
• Flexible thinking - able to challenge and see views from different perspectives
• Ability to self-motivate and be resilient and focused under pressure
• Able to effectively enable and drive change across cross functional stakeholders
• Strong general computer literacy with Intermediate skills in Microsoft Word, Excel, Power Point and Outlook
You may apply for this position online by selecting the Apply now button.
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