Gmp facility senior/executive, actris

1 month ago

Singapore Consortium For Clinical Research And Innovation Singapore Full time

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 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 Manage Facility Engineering: Assist to ensure that activities carried out by the contractor in the facility is in compliance with GMP regulations. Assist to manage equipment- and system-related investigations, CAPAs, deviations change controls and to review records. Scheduling the routine maintenance with service vendors for the maintenance to be done on time for the facility and lab & production equipment including prepare the User Request Specification (URS), obtain the quote and follow up on the PO issuance. Ensuring proper & timely maintenance, calibration and operation of all equipment, facility M&E, safety and security equipment such as HVAC, CCTVs, access control, etc. Conduct regular inspection of the office, facility and various systems supporting operations. Supervise routine planned maintenance and any necessary repair works. Maintain and upkeep a proper filling system for facilities related and equipment related documents. Assist with meeting rooms setup for events. Partner with key stakeholders to meet user requirements and optimal functioning of all laboratory & production and building spaces. To adhere with WSH management system and risk management plan, conducting regular safety inspections, addressing safety concerns, and coordinating with security personnel to prevent unauthorized access or other security threats. To ensure all vendors carrying out works in ACTRIS adhere to the WSH policy and necessary safety related requirements. Review Risk assessment and method of statement submitted by vendors. Conduct incidents investigations and make recommendations to address root cause of incidents. Managing any other operational related duties/projects as assigned. What we are looking for EDUCATION, TRAINING Diploma equivalent Facilities Related, Engineering or related fields EXPERIENCE At least 2-3 years relevant working experience in managing Good Manufacturing Practice (GMP) facilities/ cleanrooms. Knowledge of Mechanical and Electrical systems supporting GMP environment. Fire Safety and biosafety related knowledge / experience will have an added advantage. Effective stakeholder management and good communication skills. Good team player with positive work attitude. Ability to multi-task and work independently. Able to support facilities maintenance operation after office hours / during weekend when needed. 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: #J-18808-Ljbffr

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    GMP Facility Senior/Executive, ACTRIS 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...

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    Select how often (in days) to receive an alert: (Senior) Quality Operations Specialist, ACTRIS 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...

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