...and CAPAs of high complexity and related to process or technical events.
Changes including eCCs, SMRs and SAP master data (e.g. BOM)... ...delivery of operational objectives
3. Management/ Leadership
Plan, manage and execute deliverable through proper and timely request...
...regulations
Leads/ manages investigation of non-conformities (events and deviations) and complex tasks (e.g. continuous improvements,... ...(advantage)
Business
Effective report writing skills
Planning and Organizing skills
Good interpersonal and communication skills...
...clean rooms and the delegated sampling of ultrapure water and pure steam if applicable
• Organization of immediate measures in the event of a fault, reporting abnormalities to the manager; experts and operational QA
• Execution of all assigned activities in compliance...
...protocols and reports)
• Adherence to established KPI targets related to QC activities (global and local)
• Project progressing according to plan and quality expectations.
• Number and severity of cGMP issues identified during internal and external audits
• No critical...
...in full cGMP compliance.
Key responsibilities
• Lead raw material method validation/ verification and routine release testing
• Plan day to day operational activities in QCRM (i.e., housekeeping, release testing). Perform data entry, review and approval of RM packages...
...Site Name: Singapore - Tuas
Posted Date: Apr 25 2024
Purpose
Accountable for planning of all routine, non-routine, project, shut down, maintenance of manufacturing assets and systems.
Ensure adherence of all maintenance task planning, scheduling, and liaising...
...activities, lost time, …)
Fix problems which impact day to day activities As part of transformation approach on site vision production plan to be sole Synflorix manufacturing plant in whole GSK vaccine network.
Let’s do this!
You’ll find hints, tips, and guidance on...
...~ Assigned as in-charge by process/operations area to provide guidance/leadership to ensure processes are completed reliably
Planning:
~ Follow the day-to-day planning
Senior Biotechnologist
~ Assist Lead Biotechnologist or Shift Supervisor or Operations Superintendent...
...routine preventive maintenance and ad hoc work request on all plant equipment.
Support routine equipment re-qualification works.
2. Planning & Management
Take personal responsibility for quality in all aspects of maintenance work that will have impact on product quality....
...techniques (advantage)
Laboratory experience in the pharmaceutical industry (advantage)
What do we offer you?
Develop strong planning and organizing skills
Develop interpersonal skills and learn to work in a team
Understand the way of working in a GMP...
...on documentation (SOP's, WRA, Risk Assessment)
Support TS engineers on creating and reviewing maintenance procedure and maintenance plan
Support Process Equipment PQ
Routine Maintenance Scope:
Support Engineers in the operation and maintenance of Utility (Clean...
...requirements.
Provide input on aspects relating to Sterility Assurance for qualification and validation strategies.
3. Management & Planning
Proactive and timely engagement of internal or external stakeholders, as necessary
Engage the necessary stakeholders to...
...programme.
Purpose:
Develop supply requirement/replenishment schedule for Toll raw materials to ensure timely execution of production plans
Manage raw materials inventory using Material Requirements Planning (MRO) tools in SAP to ensure optimal inventory levels are kept...
...validation
Knowledge of cGLP and cGMP
Preferably with knowledge of statistics
Business
Effective report writing skills Planning and Organizing skills
Good interpersonal skills
Effective team player
Leadership skills
Competencies:
Good knowledge...
...programme.
Purpose:
~ To manage QC equipment life cycle from qualification to decommissioning including calibration and maintenance plan follow up
Key Responsibilities:
Technical responsibilities
Manage new QC equipment qualification as per change control and...
...equipment qualification
~(advantage)
~ Knowledge of cGLP & cGMP (advantage)
Business
Effective report writing skills
Planning and Organizing skills
Effective team player
Analytical skills with logical thinking
Good interpersonal skills
Leadership...
...estimating and proposal writing.
• Work with General Manager of Sales & Marketing and other Asia Pacific team members to create sales plans.
• Achieve revenue and EBITDA goals established for the territory.
• Utilize Salesforce CRM and Tank Mapping systems, keeping data...
...Support Technologist, Senior QC Support Technologist 1, 2
Basic report writing skills (preferably with legible hanwriting)
Basic planning and organizing skills (for individual time management and work planning) Good interpersonal skills
Team player
For Senior QC Support...
...requirements.
Provide input on aspects relating to Sterility Assurance for qualification and validation strategies
Management & Planning
Proactive and timely engagement of internal or external stakeholders, as necessary
Engage the necessary stakeholders to...