Average salary: SG$3,750 /monthly
More stats ...Site Name: Singapore - Tuas
Posted Date: Apr 2 2024
Purpose
A member of the QA Systems Team responsible for providing document control services for the centralised documentation system to ensure timely and accurate application.
Responsibilities
Perform formatting...
...Comprising two production buildings, an administration block, quality control laboratories, utility plant and warehousing, the facility... ...support for deviation investigations
Provide support for documentation updates
Provide support for data gathering, data analysis...
...Comprising two production buildings, an administration block, quality control laboratories, utility plant and warehousing, the facility became... ...Proficient in use of IT and software/systems, ideally document management and database systems
Strong written and oral communications...
...This role will ensure proper maintenance of QC IPC/DS (In Process control/Drug Substance) lab equipment and systems and troubleshoot to... ...Participate in carrying out laboratory investigations by identifying documents and information to support root causes.
• Prepares and/or...
...laboratory investigations (e.g., OOS, deviation) and lead change controls for QC Raw Materials
• Lead creation and revisions of RM... ...GMP Management of Quality Audit, Quality Change, Control Good Documentation
Why consider Novartis?
236 million lives were touched by Novartis...
...Posted Date: Apr 18 2024
Do you have an interest in Quality Controls where you can develop your technical and analytic skills? If... ...requirements, laboratory processes and procedures, utilization of good documentation practices and other regulatory authority requirements....
...new projects and ensure proper hand over of completed project’s documents and drawings.
Maintain and calibrate plant instrumentation for... ...GMP documents (eg. Deviation report, IOQ Protocols, Change Control and SOPs)
To learn more about Singapore GSK and our people,...
2700 SGD
...Service Executive with a specialization in shipment and inventory control. This role is pivotal in providing exceptional service to our... ...and cost-effective delivery of goods. Prepare and manage shipping documents like bills of lading, shipping labels, and customs documentation...
...Mechanical Completion and Commissioning.
Support TS engineers on documentation (SOP's, WRA, Risk Assessment)
Support TS engineers on... ...enhancement of plant asset life.
Assist in monitoring and controlling expenditures within the allocated budget.
6. Continuous Improvement...
...accountability and ownership for lifecycle management, change control and deviations pertaining to incoming materials
Provide support... ...co-ordinate the new material introduction forms and ensure documentation is complete and accurate
co-ordinate with local stakeholders...
...training to ensure methods/ knowledge are effectively transferred to routine testing team
Writes/ reviews change controls, events/ deviations, CAPAs and GMP documents (e.g. SOP, protocols, reports)
Provides technical expertise and consultation to routine testing team on...
...situations with supply impact.
Initiate and review deviations/change control/CAPA associated with incoming material.
Executive 1: Minor... ...Release and Warehouse oversight
Support incoming material documentation review and release to recommend and confirm Usage Decision (UD)...
...Hsien Loong, coinciding with our 50th anniversary in Singapore. Comprising two production buildings, an administration block, quality control laboratories, utility plant and warehousing, the facility became operational in 2011. The facility and operations meet the high...
...Hsien Loong, coinciding with our 50th anniversary in Singapore. Comprising two production buildings, an administration block, quality control laboratories, utility plant and warehousing, the facility became operational in 2011. The facility and operations meet the high...
...Hsien Loong, coinciding with our 50th anniversary in Singapore. Comprising two production buildings, an administration block, quality control laboratories, utility plant and warehousing, the facility became operational in 2011. The facility and operations meet the high...
...Hsien Loong, coinciding with our 50th anniversary in Singapore. Comprising two production buildings, an administration block, quality control laboratories, utility plant and warehousing, the facility became operational in 2011. The facility and operations meet the high...
...Hsien Loong, coinciding with our 50th anniversary in Singapore. Comprising two production buildings, an administration block, quality control laboratories, utility plant and warehousing, the facility became operational in 2011. The facility and operations meet the high...
...with minimum 7 years in process or related industry
Good knowledge in maintenance, calibration & operation principles of process control instrument in process or chemical plants.
Good understanding of standard engineering practices, GMP guide and relevant maintenance...
...procedures and techniques.
3. Experience in application of expertise and knowledge for the following domains:
Bioburden & Endotoxin control
Aseptic process simulation
Sterile hold-time (SHT) & Container closure integrity test (CCIT)
Sterilisation methods,...
...SAP master data (e.g. BOM).
Non-process specific training.
Gap analysis against QMS (CQMPs, GGs) and Quality Alerts.
Prepare documents and training materials as required to support the activities of the operations department.
Identify, manage, and execute...
...and communities we serve.
Role Requirements :
Essential Requirements:
• 3+ years of experience in pharmaceutical quality control, quality assurance or production
• Operations Management and Execution; Functional Breadth; Collaborating across boundaries; Applied...
...analytical data / tests (analytical release) Suggest improvement actions (organization, process, safety, hygiene, etc.) at shop floor -Documentation Specialist GMP
• Prepare, print and consolidate the batch documents, labels... and handover to production operators within the...
...job (OJT) training as assigned.
Quality
Comply with all relevant SOP/Batch record requirements.
Perform timely review of documentation and make necessary corrections.
Have good quality mindset and integrity to ensure products are manufactured with the highest...
...technical expertise to ensure that manufactured products meet applicable regulatory standards and guidelines with respect to Quality control operations
Prepares and updates LSOP/ protocols.
Participates in investigation of non-conformities (deviations and exceptions)...
...OJT) training as assigned .
Quality:
Comply with all relevant SOP/Batch record requirements.
Perform timely review of documentation and make necessary corrections .
Have good quality mindset and integrity to ensure products are manufactured with the highest...
...maintenance plan follow up
Key Responsibilities:
Technical responsibilities
Manage new QC equipment qualification as per change control and validation processes (i.e. URS, System classification, Audit trail review assessment, DQ/IQ/OQ, PPC09)
Be author of SOPs/...
...testing in the following areas with good observation of GMP requirements:
Biological testings for raw materials release (All QA controlled materials). Biological testings refer to biochemistry and/ or microbiological testings.
Biological testings for intermediates and...
...discipline.
Technical
~Experience in application of expertise and knowledge for the following domains:
~ Bioburden & endotoxin control
~ Media Simulation
~ SHT &CCIT
~ Sterilisation Methods
~ VHP Changeover Cleaning Disinfection
~ Aseptic Practice
~ EM...
...local procedures throughout the project lifecycle with regards to qualification and validation
Deploys the appropriate project documentation through the project lifecycle.
Identify and anticipate potential quality issue during the course of the project execution and avoid...
...laboratory investigation (when required) and assist in the timely closure investigations, CAPAs.
Ensures proper archival of submitted document for easy retrieval
Identifies and reports problems in QC to supervisor in a timely manner.
Adheres to all safety and security...