Overview
Manager, Quality Operations, ACTRIS Jobs in Singapore, Singapore at Consortium for Clinical Research and Innovation Singapore
Position: Manager, Quality Operations, ACTRIS 1
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.
Business Entities under CRIS include:
Singapore
Clinical Research
Institute (SCRI)
Advanced Cell Therapy and Research Institute, Singapore (ACTRIS)
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!
ACTRISThe 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:
Provide Quality Oversight for Good Manufacturing Practices / Good Document and Data Practices activities.
Process Owner and Administrator for Quality Operations related policies and SOPs.Provide quality oversight for Gap and/or quality risk assessments between assigned quality management process and applicable CTGTP / GMP / GDP regulations, guidance and industry standards.
Review and provide inputs to batch records, batch disposition, batch release, training requirements, change controls, deviations, CAPA and investigations.
Lead and/or support internal audits and external inspections preparation.
Lead and/or participate in Quality Management Review.
Identify and communicate compliance risks to Head, Quality.
Other responsibilities as assigned by Head, Quality.
What we are looking for:
EDUCATION
, TRAINING:
Degree in Science, Engineering and Life Sciences.
Certified Quality Manager (Preferred).
EXPERIENCE:
A minimum of 5 to 10 years of relevant working experience in Pharmaceutical Quality Systems in GMP / GDP / ATMP relevant industry.
Relevant knowledge in GMP / GDP / HSA / HPRA regulatory requirements.
Proficient in Quality Management Concepts.
What you need to know:
Successful candidate will be offered a 3-year contract, renewable. We regret that only shortlisted candidates will be contacted. For more information about CRIS and the Business Entities, visit our websites below:
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Title: Manager, Quality Operations, ACTRIS
Company: Consortium for Clinical Research and Innovation Singapore
Location: Singapore, Singapore
Category: Healthcare, Quality Assurance – QA/QC
