- Assure Company's compliance with applicable federal, state, and local regulations as well as corporate policies to avoid any business interruptions. Communicate all identified compliance and quality risks to supervisor.
- Perform compliance assessments of site and cross-site Quality Systems (process inspections/facility inspections/equipment and record review/computer validation activities; and/or training records) including review of client audit observations.
- Review SOPs, protocols/batch records, reports, quality and regulated records (e.g. deviations, change controls, or CAPA) involving technically complex issues and processes for accuracy and compliance with all applicable regulations and internal policies.
- Participate in the process for identifying recommendations to Operations and Quality Management for improvements in auditing of quality systems.
- Participate in the preparation of study and QA files in preparation for sponsor site visits and regulatory inspections. May participate in the support of client site visits.
- Assist in the development of recommendations for corrective and preventative actions to respond to client visit and regulatory inspection findings.
- Participate in the execution of site-wide applicable regulations or standards (ISO/GLP/GMP) training sessions, as developed and approved by senior Quality Systems team members.
- Participate in the preparation of support during regulatory inspections, as required.
- Participate in the performance of internal facility inspections at planned intervals to evaluate effective control and maintenance of site quality systems. Maintain written and signed records of all audits and inspections as required and may sign records documenting the performance of audits and inspections and reporting to management.
- Perform facility and equipment records and logbook reviews.
- Where appropriate, approve customer test reports and participate in reagent release activities to support laboratory operations.
- Assist in correction of any regulatory risk areas as identified by Senior Quality Systems team members.
- Participate in inspections and audits of subcontractors, vendors, and suppliers of products and services.
- Assist with analysis and collection of site Quality Metrics via QMS.
- Assist with preparations for Quality Management Review (QMR).
- Participate in the execution of identified process-improvement for dashboard analysis and analyze metric data for QMS.
- Participate in execution of Quality Assurance projects.
- Assist with providing basic regulatory training to operations personnel.
- Provide timely responses to Customer inquiries to support their qualification / regulatory requests.
- Education: Bachelor's degree (B.S. / BA.A.) or equivalent, preferably in a life science.
- Experience: Minimum of 2 years in a Quality Assurance role.
- An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
- Others: May require occasional domestic and/or international travel (up to 10%) for customer site visit.
- May occasionally be required to wear protective clothing and equipment.
-
System Specialist
1 week ago
NITYO INFOTECH SERVICES PTE. LTD. SingaporeNityo Infotech is looking for a Systems Specialist. This is a permanent role with Nityo, deployed to client's site in the healthcare environment. · Scope of work include: · - EUC/Systems Specialist will be the Subject Matter Expert and technically proficient who will provide tech ...
-
System Specialist
1 week ago
NITYO INFOTECH SERVICES PTE. LTD. SingaporeNityo Infotech is looking for a Systems Specialist. This is a permanent role with Nityo, deployed to client's site in the healthcare environment. · Scope of work include: · - EUC/Systems Specialist will be the Subject Matter Expert and technically proficient who will provide tech ...
-
System Specialist
1 week ago
THOMSON MEDICAL PTE. LTD. SingaporeSystem Specialist is responsible to develop, maintain and support an organisation's IT systems, such as computer hardware, software, video conferencing, networks and database systems and servers. He / She is to ensure that the IT environment is secure and available at all times. ...
-
Systems Specialist
13 hours ago
Housing and Development Board Singapore**About Us** · The mission of Housing & Development Board (HDB) is to provide affordable, quality housing and a great living environment where communities thrive. To achieve its mission, HDB aims to be data-driven to the core and adopt evidence-based decision making in developing ...
-
Systems Specialist
13 hours ago
SQUAREPOINT SERVICES SINGAPORE PTE. LTD. Singapore**Position Platform Specialist** · **Business Area Technology Infrastructure · Squarepoint is a global investment management firm that utilizes a diversified portfolio of systematic and quantitative strategies across financial markets that seeks to achieve high quality, uncorrela ...
-
System Specialist
4 days ago
SUPREME MARITIME SERVICES PTE. LTD. Singapore**RESPONSIBILITIES: · - ** · - Daily support in ERP, shipping system including maintenance and continuous improvement. · - Responsible for sorting and analysing business requirements and co-operate within departments locally and overseas. · - Liaise with vendors to perform system ...
-
System Specialist
3 days ago
PERSOLKELLY Singapore Singapore**Responsibilities** · - Conduct user requirement analysis for the implementation and rollout of new system · - Manage project schedules and ensure projects are delivered in time. · - Conduct in various tests, include System Pre-testing, Equipment Testing, UAT, System Integration ...
-
Systems Specialist
4 days ago
MHA - Internal Security Department (ISD) Singapore**What the role is** · - ISD confronts and addresses threats to Singapore's internal security and stability. For over 70 years, ISD and its predecessor organisations have played a central role in countering threats such as those posed by foreign subversive elements, spies, racial ...
-
System Support Specialist
4 days ago
RECRUITPEDIA PTE. LTD. Singapore**Our client is a global MNC in providing engineering solutions. Due to their current expansion plan, they are looking for a System Support Specialist to join their WMS Support Team, in hopes of developing the current high performing team. They are located in East area - easily a ...
-
HR Systems Specialist
1 week ago
SingHealth Group SingaporeSengkang General Hospital Pte. Ltd.**HR Systems Specialist**: · - Job Category: Administration- Posting Date: 25 Jan 2024You will manage the full suite of the Human Resource Information System (HRIS) modules and ensure efficient functioning of the HR online portals. These include ...
-
Systems Specialist, Maximo
13 hours ago
SMRT Corporation Ltd SingaporeSystems Specialist, Maximo · **Job Purpose** · - As a Maximo Techno-Functional Consultant (System Specialist), you will be responsible for providing technical and functional expertise in the implementation, customization, and support of the Maximo enterprise asset management syst ...
-
HR Systems Specialist
2 days ago
SingHealth Group SingaporeSingHealth Polyclinics**HR Systems Specialist**: · - Job Category: Administration- Posting Date: 21 Feb 2024Job scope includes: · - providing documentations and user guides on the human resources data systems · - supporting documentation of system and data security management · - ...
-
Autonomous Systems Specialist
1 day ago
Singapore Technologies Engineering Ltd Singapore**Date**:2 Nov 2023 · **Location**: Singapore, SG · **Company**:ST Engineering Group · **Autonomous Systems Specialist** · **Responsibilities**: · - Research, develop and implement algorithms for autonomouscontrol of unmanned surface vessels · - Maintain and enhance code base for ...
-
IT Specialist/ System Administrator
2 days ago
MEOD PTE. LTD. SingaporeJoin our dynamic team at the urban farm, one of the largest CEA farms in Singapore, working towards contributing to our national goal of 30 by 30. Our mission is to bring freshness to the masses and inspire healthier living through sustainable urban farming. From soil to soul, we ...
-
Senior Systems Analyst/systems Specialist
4 days ago
SMRT Corporation Ltd SingaporeSenior Systems Analyst/Systems Specialist (SAP HR) · **Job Purpose** · - The Senior Systems Analyst / Systems Specialist will assist in managing all design of SAP HR module configuration and reporting including translating business requirements into functional blueprint and speci ...
-
Information Systems Specialist
1 week ago
Kuehne+Nagel SingaporeYou will be part of our Contract Logistics team, adding your technical expertise + skills to the delivery of Customer + Operational Excellence. · - ** Your Role **:To support our Warehouse Management + Transport Management Solutions (WMS + TMS) ensuring professional, timely + acc ...
-
System Specialist Manager
2 days ago
Dynamic Human Capital SingaporeJob Description · As the System Specialist, you will be responsible for managing and maintaining the digital system comprising of the Telephony, Customer Relationship Management and Knowledge Management system used within Contact Centre. Working closely with the business users, y ...
-
Network & Systems Specialist
1 week ago
EVANTAGE TECHNOLOGY PTE. LTD. SingaporeAs a Network & Systems Specialist, you will be representing the company to deliver quality support and service to our clients by troubleshooting and resolving their issues. You will also be regarded as a knowledgeable escalation point for complex technical issues within the engin ...
-
System Automation Specialist
1 week ago
INTELLECTUALS TECHNOLOGIES PTE. LTD. Singapore**System Automation Specialist - specialised in Network and Connectivity · **Roles & Responsibilities**: · - Serve as the Subject Matter Expert (SME) in the **automation **and development of Cloudinfrastructure solutions in the Network domain area, eg. on-premise networking and C ...
-
Quality Systems Specialist
3 days ago
INTERNATIONAL WORKPLACE CONSULTING PTE. LTD. SingaporeOur MNC client is hiring They are a global leader in the discovery, development and safe manufacture of new drug therapies. · The vacancy - **Quality Systems Specialist **is an important role in the compliance and quality department. · You must be someone who is able to regularly ...
Quality Systems Specialist - Singapore - INTERNATIONAL WORKPLACE CONSULTING PTE. LTD.
Description
Roles & ResponsibilitiesOur MNC client is hiring They are a global leader in the discovery, development and safe manufacture of new drug therapies.
The vacancy - Quality Systems Specialist is an important role in the compliance and quality department.
Fresh degree graduates with 2/3 years experience in QC work, who are keen to move to QA, are welcome to apply.
Relevant training will be provided but you must be someone who wants to learn, wants to taught and detail oriented.
You must be someone who is able to regularly communicate with employees/customers; must be able to exchange accurate information.
Can easily grasp instructions; attention to detail with strong writing skills.
The Role
The Person
CAPA
FDA
Quality Management
Quality Assurance
Quality System
ISO
Manufacturing Operations
Compliance
Attention to Detail
Life Sciences
Laboratory
Writing Skills
Audit