Assistant Manager/manager, Quality Operations - Singapore - Consortium for Clinical Research and Innovation Singapore

Consortium for Clinical Research and Innovation Singapore

Verified Company

Singapore

1 week ago

Posted by:

Wei Jie

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Description

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

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 supports internal audits and external inspections preparation.
Lead and/or participates 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 3 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