...Quality Controls where you can develop your technical and analytic skills? If so, this is the role for you.
As Quality Control Associates or Senior, you will be responsible for conducting sample testing of incoming materials and/or finished products to ensure compliance...
Site Name: Singapore - Tuas
Posted Date: Apr 2 2024
Purpose
To perform sampling/testing and support related activities in QC Biological team.
Responsibilities
1. Perform routine and adhoc/ non-routine testing in the following areas with good observation of ...
...the Senior Superintendent/Superintendent in the management and operations of the team; may be indirectly responsible for a team of associates:
Scheduling day-to-day shopfloor activities and resources handling to ensure timely availability of test results
Reviews test...
...and participate in health authorities inspections and internal audits in respective area.
• Provide on the job guidance to new job holders... ...the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this...
...deviation
initiate, manage and own change controls, deviations and associated CAPA for existing and new incoming materials
evaluate the... ...for planning/provisioning monitoring
Ensure that routine audits are carried out in compliance with cGMP & authorized procedures...
...risk assessments. Preparation and participation to internal HSE audits
Commitment to Diversity & Inclusion: :
We are committed... ...the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this...
...control and validation processes (i.e. URS, System classification, Audit trail review assessment, DQ/IQ/OQ, PPC09)
Be author of SOPs/... ...QC
Coordinates and supports all L2, L3 and L4 audits and the associated CAPAs
Lead and manage continuous improvement projects Subject...
...pharmaceutical industry Collaborating across boundaries.
• Expertise in GxP operations. Operations Management and Execution.
• Associate to work on 12hrs rotating shift work in Downstream Process.
Desirable Requirements:
• Working experience within the pharmaceutical...
...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 and troubleshoot on documentation...
...environmental requirements
Key Responsibilities:
Operations:
Adhere to cGMP and safety requirements
Ensure good housekeeping of associated production facilities so that they are kept in good operational order
Identify areas for improvement and participate in...
...Materials
• Lead creation and revisions of RM testing monographs
• Prepare and participate in health authority inspections and internal audits
• Other duties or projects assigned by the QC Team Leader – Raw Materials Commitment to Diversity & Inclusion: :
We are...
...activities under maintenance team are completed on schedule.
Lead investigation to instrument failure to prevent occurrences and support audit
Provide support to new project construction and commissioning activities.
Quality
Familiar with Global SOP, Local SOP, Good...
...Conducts quality checks with owners, where appropriate, upon completion of the work
Co-ordinate, organize and supervise contractor work associated with multi-disciplinary activities, e.g. annual statutory inspection
Comply with related Group Quality Policy requirements and...
2700 SGD
...levels and coordinate with the supply chain team to ensure product availability for orders. Assist in inventory control procedures and audits to maintain accurate stock records. Use inventory management software to update and maintain inventory data.
Shipment Coordination:...
...and site SOPs, GEP and GDP.
Exercise proper good documentation and record system to ensure quality assurance operations.
Ensure audit readiness.
Ensure corrective action/preventive action (CAPA) is in place to eliminate quality related deviations.
5. Costs
Participate...
...internal stakeholders in formulating actions rising from such evaluations
Provide inputs in supporting site inspections and supplier audits for matters relating to Sterility Assurance
Apply risk management skills effectively
Ability to apply optimal quality assurance...
...technical matters to ensure compliance to applicable corporate, regulatory and external agency regulations
Subject-Matter-Expert (SME) audit fronter for assigned topics
Supports local compendium system
Performs review of compendium updates timely and accurately....