Total 4 regional recruitment lead job vacancies in Quality Assurance / Control category in D12 Balestier, Serangoon, Toa Payoh

KEY ROLES AND RESPONSIBILITIES

• Develop, implement, and maintain document control processes and procedures in compliance with ISO 9001, and other quality system requirements
• Implement processes and system to cover key areas not limited to: Storage file management, Indexing, Version control, Doc check in and out, Security/Access, Archiving Rules and Auto doc num generation
• Manage the development and revision of controlled documents, ensuring all changes are approved by the appropriate personnel in a timely manner
• Maintain the master list of controlled documents, ensuring all documents are properly labeled and stored.
• Distribute controlled documents to authorized personnel, maintaining records of distribution.
• Train new employees on document control procedures
• Investigate and resolve document control non-conformances.
• Perform audits of the document control system to ensure compliance.
• Update document control procedures as needed.
• Generate reports on the status of document control activities
• Maintain confidentiality of all company information
• Adhere to all safety policies and procedures
• Coordinate with other departments to ensure all relevant documents are under control
• Plan and conduct meetings with stakeholders and presentations related to document management.

QUALIFICATIONS & EXPERIENCE

• Bachelor’s degree in business, engineering, or related field
• 5+ years experience in document control or a similar role
• Working knowledge of quality management systems (ISO 9001)
• Experience with project management software, such as Microsoft Project
• Proficient in SharePoint is preferred
• Proficient in Microsoft Office, Adobe Acrobat, and Docusign
• Familiarity with records management principles

SKILLS/COMPETENCIES & PREFERRED CHARACTERISTICS

• Proficient in the use of SharePoint, Microsoft Word, Excel and PowerPoint and ability to learn other job-related programs and software.
• Detail oriented individual with proven ability to work independently and as part of a team to prioritize work, multi-task and get results.
• ·Excellent Interpersonal and communication skills

Key Highlights:

• Starting salary from $3,500 + Allowance + Performance Bonus

• New headcounts as part of business expansion plans

• Career advancement opportunities

Job Scope:

• Conduct full range of audit for listed companies and SMEs, both in Singapore and overseas, from planning to completion, monitoring the engagement progress against budget and timeline

• Develop good problem-solving skills and provide sound recommendation of management actions based on industry research, insightful analysis and investigation

• Promote positive team work - coach junior employees, share learnings, understand how own work impacts others

• Attend client meetings, contribute by supporting senior team members

• Other ad-hoc duties as assigned by Supervisor

Job Requirement:

• Degree or professional accounting qualifications recognised by ISCA

• Minimum 1-2 years’ relevant experience with large/mid-tier international accounting firms

• Proactive, committed and able to work under pressure

• Possess initiative and the ability to work independently

• Team player

For interested applicants, kindly send a copy of your resume to [email protected] or simply click the button to APPLY NOW! We regret that only shortlisted applicants will be notified.

EA Licence No.: 16C8261 | EA Personnel: Tan Jessie | EA Personnel Reg. No: R1879285

ROLE: Responsible for GMP-compliant quality control tests of cell products

JOB SCOPE:

1. Performing quality control tests for clinical materials (cell therapy products) according to GMP standards.
2. Work with the Cell Manufacturing & Quality Assurance Team.
3. Ensuring GMP compliance is maintained at all times.
4. Be accountable for the highest level of execution of regulatory strategies, and standards of quality compliance.

EXPERIENCE REQUIREMENTS:

1. Experience in quality control tests of biologics or immune cell products, previous quality test experience of CAR-T/TCR-T/NK cell products is highly desired.
2. Experience in regulatory filing with FDA/HSA is desired.
3. Familiar with regular testing methods such as sterility/mycoplasma/endotoxin detection, flow cytometry analysis; Cytokine measurement assays; qPCR assays; etc.
4. Self-motivated, good interpersonal skills.
5. Project management experiences.

EDUCATIONAL REQUIREMENTS:

• Bachelor & more advanced degree in cell biology /biomedical sciences or in a similar medical technology related field.

PURPOSE AND SCOPE

KEY ROLES AND RESPONSIBILITIES

• Develop, implement, and maintain document control processes and procedures in compliance with ISO 9001, and other quality system requirements
• Implement processes and system to cover key areas not limited to: Storage file management, Indexing, Version control, Doc check in and out, Security/Access, Archiving Rules and Auto doc num generation
• Manage the development and revision of controlled documents, ensuring all changes are approved by the appropriate personnel in a timely manner
• Maintain the master list of controlled documents, ensuring all documents are properly labeled and stored.
• Distribute controlled documents to authorized personnel, maintaining records of distribution.
• Train new employees on document control procedures
• Investigate and resolve document control non-conformances.
• Perform audits of the document control system to ensure compliance.
• Update document control procedures as needed.
• Generate reports on the status of document control activities
• Maintain confidentiality of all company information
• Adhere to all safety policies and procedures
• Coordinate with other departments to ensure all relevant documents are under control
• Plan and conduct meetings with stakeholders and presentations related to document management.

QUALIFICATIONS & EXPERIENCE

• Bachelor’s degree in business, engineering, or related field
• 5+ years experience in document control or a similar role
• Working knowledge of quality management systems (ISO 9001)
• Experience with project management software, such as Microsoft Project
• Proficient in SharePoint is preferred
• Proficient in Microsoft Office, Adobe Acrobat, and Docusign
• Familiarity with records management principles

SKILLS/COMPETENCIES & PREFERRED CHARACTERISTICS

• Proficient in the use of SharePoint, Microsoft Word, Excel and PowerPoint and ability to learn other job-related programs and software.
• Detail oriented individual with proven ability to work independently and as part of a team to prioritize work, multi-task and get results.
• ·Excellent Interpersonal and communication skills