...Understand the vaccine manufacturing process and systems
Provide support to continuous improvement initiatives
Provide support for deviation investigations
Provide support for documentation updates
Provide support for data gathering, data analysis and trending...
...operational objectives. Areas of support includes process optimization, validation activities, continuous improvement, change management, deviation investigation and production project management to ensure that Value Stream can operate optimally and in compliance with cGMP...
...and perform technical reviews of procedures and testing monographs for raw materials
• Lead laboratory investigations (e.g., OOS, deviation) and lead change controls for QC Raw Materials
• Lead creation and revisions of RM testing monographs
• Prepare and participate...
...of experience in troubleshooting instruments failure
Experience in GMP environment
Experience in preparing GMP documents (eg. Deviation report, IOQ Protocols, Change Control and SOPs)
To learn more about Singapore GSK and our people, please click on this link:...
...observation of GMP requirements - Biological testing for material releases
Participate and initiate laboratory investigations (OOS/deviations)
Perform equipment calibration, maintenance and validation
Participate in method transfer, verification and validation....
...corrections.
Have good quality mindset and integrity to ensure products are manufactured with the highest quality
Participate in deviation investigation process (Process, Environmental, Maintenance/Equipment, QC) and implementation of Corrective and Preventive Action (...
...sampling labels) in a timely manner, as required.
Initiate improvements to document management system / workflow.
Support in deviations / Change Controls / CAPAs associated with document system.
Generate required metrices for document management.
Support consultations...
...corrections .
Have good quality mindset and integrity to ensure products are manufactured with the highest quality
Participate in deviation investigation process (Process, Environmental , Maintenance/Equipmen , t QC) and implementation of Corrective and Preventive...
...operations.
Ensure audit readiness.
Ensure corrective action/preventive action (CAPA) is in place to eliminate quality related deviations.
5. Costs
Participate in implementing cost-effective solutions in the upkeep and enhancement of plant asset life.
Assist...
...Perform routine environmental monitoring of classified environment.
2. Initiate and participate in laboratory investigation (OOS / deviations / atypical results / invalid results) and assist in timely closure of the investigation and CAPA.
3. Perform equipment maintenance...
...material usage revision and material replacement
Provide accountability and ownership for lifecycle management, change control and deviations pertaining to incoming materials
Provide support to the management of business master data in ERP system for all planning-related...
...operations.
Decision Making
Proposals & Recommendations
Based on experience & knowledge of work
Proposal of CAPA for any issues/deviations/exceptions
Proposal on QC improvement projects and strategies
Staff training and development
Skills:
Education...
...to applicable corporate, regulatory and external agency regulations
Leads/ manages investigation of non-conformities (events and deviations) and complex tasks (e.g. continuous improvements, department/ site projects and initiatives)
Knowledge management on knowledge retention...
...budget
Decision Making
Proposals & Recommendations
Based on experience & knowledge of work
Proposal of CAPA for any issues/ deviations/ exceptions/ risks
Proposal of QC improvement projects and strategies
Team training and development
Skills:...
...Perform routine environmental sampling in controlled environmental areas
Initiate and participate in laboratory investigation (OOS / deviations / atypical results / invalid results) and assist in timely closure of the investigation and CAPA
Perform equipment calibration,...
...change notifications in a timely manner and escalate where necessary especially in situations with supply impact.
Initiate and review deviations/change control/CAPA associated with incoming material.
Executive 1: Minor deviations and CAPA
Executive 2: Minor, major...