Average salary: SG$5,750 /monthly
More statsSearch Results: 22 vacancies
...testing SOP’s and local/international regulations.
Key Responsibilities:
Establish and maintain QC Biochemistry lab in full cGMP-compliance.
Review and validate product testing results and analysis under cGMP and meet required timelines.
Provides technical support...
...Development
~ Ensure training and development of members in the team.
4. Quality
Ensure quality of product by operating in compliance with GMP requirements
Ensure deviation investigations are performed promptly and appropriate CAPAs being put in place to address...
...investigational support, research support, and stability testing.
Key Responsibilities:
Maintain QC Raw Materials laboratory in full cGMP compliance.
Lead raw material method validation/ verification and routine release testing
Plan day to day operational activities in QCRM...
...corrective actions to increase yield, maximise capacity, reduce costs and decrease process variability while maintaining regulatory compliance.
Promote process/product/device improvements, create data packages by justifying and outlining recommendations for changes to or...
...manufacturing operation, new product launches/transfer in a compliant/timely manner, drug substance batch review/release are in full gmp compliance to regulatory standards and ensures quality strategy/continuous improvement are driven in alignment to site objective/s.
About the...
...implement and execute maintenance programs using SAP and other maintenance best practices/ tools in a safe and cost-effective manner and in compliance with requirements.
2. Automation
Ensure automation system operate smoothly and deliver the required reliability and...
...on Good Documentation practices relating to archival
Be involved in deviation investigations if any
Support data collation and compliance sampling (documentation check) activities for the annual system effectiveness review
Support logistics and activities for audit...
...Maintenance/Equipment, QC) and implementation of Corrective and Preventive Action (CAPA)
Participate in cGMP self-inspections to ensure compliance with internal SOPs and regulatory requirements
Reporting/Documentation
Operate key computer applications related to...
...Manufacturing and Laboratory operations
Support qualification activities
Ensure that the project execution activities are carried in a compliance manner to company policies and regulatory guidelines.
Implement improvements and streamline work processes
What are we...
Summary
Responsible for operational leadership of a defined area within the site’s QA Operations unit. Ensure compliance with all cGxP, regulatory and HSE aspects as well as responsible for people leadership within are of responsibility.
About the Role
Quality Team Leader...
...housekeeping is maintained.
Maintain awareness in SEHS within Maintenance section.
Provide full support and accountability on compliance to SSOW systems (eg. PTW, LOTO)
4. Quality
Ensure that all maintenance and calibration activities are carried out in compliance...
.../Equipmen , t QC) and implementation of Corrective and Preventive Action (CAPA)
Participate in cGMP self-inspections to ensure compliance with internal SOPs and regulatory requirements
Reporting/Documentation:
Operate key computer applications related to production...
...change management, deviation investigation and production project management to ensure that Value Stream can operate optimally and in compliance with cGMP requirements.
Responsibilities
1. Operations
a) To support Manufacturing Operations in the following areas:...
Summary
Responsible for managing quality aspects within area of responsibility and to ensure that the operational business is in compliance with cGMP (Current Good Manufacturing Practices), the Quality Assurance Agreement, regulatory requirements and the Novartis Quality...
...indicators (KPI) for the supply chain, especially for planning/provisioning monitoring
Ensure that routine audits are carried out in compliance with cGMP & authorized procedures and policies
Ensure timely maintenance of business master data (planning related) in a...
...incubators
Liaise with external vendor for service quotation, escort vendor during service and approve invoice timely
Supports compliance activities:
Performs regular Ll audits in QC
Coordinates and supports all L2, L3 and L4 audits and the associated CAPAs...
...compendial updates
Keeps up-to-date on regulations/ development of biopharmaceutical QC activities to ensure QC operations are in compliance to applicable corporate, regulatory and external agency regulations
Leads/ manages investigation of non-conformities (events and...
...exceptions) and close the report on time.
Performs data trending and co-ordinates with relevant parties. Reviews QC reports to ensure compliance and promptness of results.
Problem solving
Identifies and reports problems in QC. Solve problems and implement corrective...
...teams
Work in collaboration with Quality Assurance to establish and maintain high standards of cGMP for site SAP activities in compliance with GSK and regulatory standards
Ensure inspection readiness at all times
Support regulatory audits/inspections
Follow-up...
...operations.
Key Responsibilities:
Supplier Management
Provide QA oversight of Supplier management activities on site to achieve compliance with company policies and government regulations as assigned.
To participate (Executive 1) and to represent the site (Executive 2...
