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Assistant Manager, Quality

2 weeks ago

Central Singapore CONSORTIUM FOR CLINICAL RESEARCH AND INNOVATION, SINGAPORE PTE. LTD. Full time

**Location**
- Singapore, Central Singapore**Job Type**
- Contract**Salary**
- $3,800 - $5,400 Per Month**Date Posted**
- 2 hours agoAdditional Details

**Job ID**
- 128697**Job Views**
- 1Roles & Responsibilities

**About ACTRIS**

The Advanced Cell Therapy andResearch Institute, Singapore (ACTRIS) was established on 20 April 2020 to meetthe increasing clinical demand of using cellular therapeutics to treat variouslife-threatening diseases. ACTRIS’s vision is to be the national and regionalCentre of Excellence for discovery, process development and manufacturing ofcellular-based therapeutics across the broad spectrum of immunotherapy andregenerative medicine, encompassing both investigational and approval productsfor the local market. ACTRIS aims to achieve accreditation from national andinternational regulators to ensure quality compliance of resource-efficientcellular therapy manufacturing. Our common goal is to promote and foster theentire value of chain of cellular therapy ecosystem through enablingtranslational research and development, manufacturing, clinical serviceprovision, and commercialisation by serving the healthcare, academic and industrialsectors. ACTRIS will also provide value-added services such as workforcetraining, regulatory facilitation and ancillary material standardization,pertaining to delivery of cellular therapy to patients.

The Assistant Manager will develop, oversee and manage thequality management system withinthe Quality Office of ACTRIS. The role also ensures the quality managementsystem which comprises quality assurance and quality control are implementedwithin the scheduled time and budget, and with good quality, in closecoordination with both internal and external stakeholders.

The duties and responsibilities include:

- Tod evelop and oversee both quality assurance and quality control functions acrossall GxP processes (GxP refers to Good Manufacturing Practice (GMP), Good TissuePractice (GTP), Good Distribution Practice (GDP) and Good Clinical Practice (GCP);
- To improve current quality management systems whichincludes Corrective ActionPreventive Action (CAPA), Change Control, Document Control, Risk Management,identification of Critical Quality Events and establish strategic quality objectives in support variousmanufacturing programmes;
- To identify, select and implement scalable software to support quality systems;
- To develop/maintain internal and external auditprogrammes to satisfy contractual and regulatory requirements of GxP;
- To coordinate the quality review of documentsfor regulatory submissions and oversee inspections conducted by both local andinternational regulatory bodies;
- To provide regulatory guidance and feedback tothe design of the facility;
- To establish adequate GxP training programmesto support the growth of the facility; and
- To supervise and develop staff in the quality assurance and quality control departments;

**Requirements**:

- At least 5 years of work experience in cGMP operations with knowledge in the development of GMP facilities and understanding of PIC/S Guideline, HSA HealthProduct Acts and HSA Guidelines on GMP for Cell, Tissue and Gene TherapyProducts
- Experience in implementation of ICH Q10 QualitySystems, especially Risk Analysis/Management, CAPA, Annual Product Reviews and Management Review and Supplier Quality Management;
- Able to perform lot release, data review, conductlaboratory and facility audits;
- Excellent team player and good communication skills;
- Proficient in Microsoft Office.

Tags

assistant

manager

quality

3

year

contract