Senior/quality Specialist

2 days ago

Singapore Consortium for Clinical Research and Innovation Singapore Full time

**Overview**

The Consortium for Clinical Research and Innovation, Singapore (CRIS) brings together six national R&D, clinical translation and service programmes to advance clinical research and innovation for Singapore, and establish important capabilities for a future-ready healthcare system.

The Business Entities under CRIS include:

- Singapore Clinical Research Institute (SCRI)
- National Health Innovation Centre (NHIC)
- Advanced Cell Therapy and Research Institute, Singapore (ACTRIS)
- Precision Health Research, Singapore (PRECISE)
- Singapore Translational Cancer Consortium (STCC)
- Cardiovascular Disease National Collaborative Enterprise (CADENCE)

Together, CRIS makes a positive difference to Singapore patients and researchers by ensuring that these clinical research platforms and programmes are at the cutting edge of capability development and innovation. If you are as passionate as we are in clinical trials and research, we want you

**ACTRIS**

The Advanced Cell Therapy and Research Institute, Singapore (ACTRIS) was established to meet the increasing clinical demand of using cellular therapeutics to treat various life-threatening diseases. ACTRIS’ vision is to be the national and regional Centre of Excellence for discovery, process development and manufacturing of cellular-based therapeutics across the broad spectrum of immunotherapy and regenerative medicine, encompassing both investigational and approval products for the local market. We also provide value-added services such as workforce training, regulatory facilitation and ancillary material standardization, pertaining to delivery of cellular therapy to patients.

**What you will be working on**

The quality specialist in areas of Training and Document Management and compliance will support routine GMP operations.
- Provide Quality Oversight for Good Manufacturing Practices / Good Document and Data Practices activities.
- Assist Quality Managers in providing administration to Quality Training and Document Management related policies and SOPs.
- Provide quality oversight for Gap and/or quality risk assessments between assigned quality training and documentation management process and applicable CTGTP / GMP / GDP regulations, guidance and industry standards.
- Review and provide inputs to relevant documents, training requirements, change controls, deviations and investigations.
- Support Quality Managers in internal audits, supplier audits and external agency inspections preparation.
- Support Quality Managers in Quality Management Review.
- Maintains the ACTRIS Pharmaceutical Quality System.
- Other responsibilities as assigned by Quality Managers

**What we are looking for**

EDUCATION, TRAINING
- Diploma or Degree in Science, Engineering and Life Sciences

EXPERIENCE
- A minimum of 1 to 3 Years of relevant working experience in Pharmaceutical Quality Systems in GMP / GDP / ATMP relevant industry.
- Relevant experience in management GMP training and documentation is mandatory.
- Relevant knowledge in GMP / GDP / HSA / HPRA regulatory requirements
- Proficient in Quality Management Concepts.

**What you need to know

  • Quality Specialist

    7 days ago

    Singapore Tangibletanzania Full time

    Get AI-powered advice on this job and more exclusive features. This is a full-time on-site role for a Quality Specialist based in Singapore. The Quality Specialist will be responsible for conducting quality control, quality assurance, and quality auditing tasks. They will analyze data and processes to ensure compliance with standards and identify areas for...

  • Quality Specialist

    1 week ago

    Singapore Tangibletanzania Full time

    Description Get AI-powered advice on this job and more exclusive features. This is a full-time on-site role for a Quality Specialist based in Singapore. The Quality Specialist will be responsible for conducting quality control, quality assurance, and quality auditing tasks. They will analyze data and processes to ensure compliance with standards and identify...

  • Senior Quality Assurance Specialist

    3 days ago

    Singapore KBR Full time

    **Title**: Senior Quality Assurance Specialist Job Responsibilities Reports to Project Quality Manager Implements contractually required standards for project execution Supports PQM in maintaining project Audit programme Conducts / Participates in Project Audits To prepare, issue and monitor the internal quality audit reports Trending and Follow-up to...

  • Senior Quality Specialist

    1 week ago

    Singapore Merck Group Full time

    Work Your Magic with us! Ready to explore, break barriers, and discover more? We know you’ve got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich...

  • Quality Specialist

    6 days ago

    Singapore Nestlé Full time

    Position Snapshot Location: Jurong, Singapore Company: Nestle R&D Center, Singapore Type of contract: Permanent contract Position Summary Joining Nestlé means you are joining the largest Food and Beverage Company in the world. At our very core, we are a human environment – passionate people driven by the purpose of enhancing the quality of life and...

  • Quality Assurance Specialist

    2 days ago

    Singapore Ethos BeathChapman Full time

    **Job Details**: **Location** Singapore **Salary** Competitive Salary **Job Type** Permanent **Ref** BH-176854 **Contact** Piers Atkinson- **Posted** about 1 hour ago - I am looking for a Quality Specialist to cover Singapore and Malaysia. - Company is a global business but flies a little under the radar in Singapore, with a huge range of products....

  • Specialist Quality Assurance

    3 days ago

    Singapore Amgen Full time

    **Specialist Quality Assurance I** **Amgen Singapore Manufacturing** **HOW MIGHT YOU DEFY IMAGINATION?** Amgen is one of the world’s leading independent biotechnology companies. For over 4 decades, Amgen has pioneered biotechnology breakthroughs, to bring state-of-the-art medicines from laboratory to the patient. Amgen has not only discovered and...

  • Quality Assurance Specialist

    2 weeks ago

    Singapore KBR, Inc. Full time

    Overview Join to apply for the Quality Assurance Specialist role at KBR, Inc. Get AI-powered advice on this job and more exclusive features. Responsibilities Provides specialized technical expertise in support of the Quality program, including specialized inspection and testing techniques, quality training, statistical methods, audits, quality tools for...

  • Emergency and Critical Care Specialist

    1 week ago

    Singapore BEECROFT ANIMAL SPECIALIST SERVICES PTE. LTD. Full time $120,000 - $240,000 per year

    Job Description:Attend ECC and general hospital inpatient rounds as required during shift timings- actively contribute to case discussion to improve the standard of care provided to patients from all departments.Establish and recommend best practice diagnostics and treatment plans for patients in ICU and wards that are under ECC team's careClear and...

  • Quality Assurance Senior Specialist

    3 days ago

    Singapore CooperVision Full time

    As the CVI owner, the APAC QA Senior Specialist guarantees that the CooperVision Regional Service Center adheres to both global and regional quality management requirements. This encompasses overseeing the quality management system (QMS) to ensure compliance with Medical Device Regulations (MDR), the Medical Device Single Audit Program (MDSAP), Good...