Quality Operations Spec/ Biotechnologist/ Microbio Med Tech (Pharma Mfg)
Role 1: Quality Operations
Primary Objectives of this Job
This position is a member of the Quality Operations (QO) team in providing quality oversight to the manufacturing team to ensure GMP compliance.
• Quality Systems Representative
o Member of the QO team in ensuring quality oversight at the manufacturing suite
o Partner the manufacturing team in the implementation and adherence to the various quality systems and GMP requirements at the manufacturing suite
o Lead meetings with the manufacturing for information learning/ sharing and alignment of best practices
o Support the compliance, regulatory, inspections and training activities as required and any other responsibilities as assigned by Supervisor
• QO Operations
o Revise and participate in the development and writing of procedures pertaining to the QO operations
o Support manufacturing team with development and writing of process standard operating Procedures and master batch records and ensure that it complies with current good documentation practices and the applicable global procedures and regulatory requirements. This includes approval of the associated revision.
o Take on ownership of investigation relating to quality operations.
o Review executed Manufacturing Batch Records (MBR) and approve revision of MBR.
o Participate as SME in the gap analysis for current SOP/ practices with the various subject matter expert to ensure compliance with revision of global procedures. Where gaps are identified, ensure an implementation/ mitigation plan is in place and follow-through to completion.
o Participate in cross-functional investigations.
o Support the manufacturing team with any quality interpretation, queries and issues
• Other responsibilities (if assigned) o Render support for timely release of Bulk Drug Substances (BDS) and resolution of BDS release matters
o Provide QO related impact assessments for change controls and own change controls (relating to Quality Operations)
o Review and approve standard operating procedures
o Lead/ Participate in routine GMP walk-through with manufacturing team
o Participate in all process improvements/studies with the manufacturing team and draft test scripts/ protocols
o Perform timely archival of QO documents
o Manage cell bank and BDS Reference Samples
• Leadership o Build strong partnership with all other departments to ensure open communications and acceptance
o Commitment to a fair and respectful relationship to others and behavior in accordance with Code of Conduct.
o Responsibility to adhere to any applicable EHS requirements.
• Any other duties as assigned by supervisor.
Role 2: Biotechnologist
Primary responsibilities include:
• Perform routine and non-routine production operations as per SOPs
• Execute instructions and record data in the Electronic Batch Management (EBM) system
• Perform Clean-In-Place (CIP) /Steam-In-Place (SIP) activities as per MFR/SOP
• Perform filter integrity testing (FIT)
• Perform filtration and filter management as per SOP
• Attain good operating knowledge of the Process Control System (PCS)
• Attain good operating knowledge on the Manufacturing Execution System (MES)
• Perform equipment cleaning as per SOP
• Perform equipment monitoring
• Perform scheduled cleaning of equipment
• Acquire good knowledge in handling of consumables (e.g. Bottles, filters, autoclave assemblies, etc.)
• Perform laboratory tasks including but not limited to sampling, pH and conductivity measurements (If required), identify and report if there’s any atypical events
• Pursue on-the-job training through Competency Assessments to increase knowledge and understanding
• Record data into logbooks, log-sheets and forms (If applicable)
• Responsible for Alarm/Alert review and real time trouble-shooting
• Responsible for logbooks and log-sheets review and follow up
• Perform troubleshooting and resolve process related issues
• To participate and resolve process related issues (If required)
• Support transfer of new processes, commission or validation of new project
• Collaborate with other departments to resolve issues related to daily operations
• Training of new team members.
• Demonstrate good cleanroom technique in the handling of product and materials
• Coordinate in-process sampling and submission
• Mentor and perform On-Job-Training to team members
• Support GMP and Safety audits (If required)
• Perform 5S housekeeping
• Support transfer of new processes and commission/validation of new projects (If required)
• Carry out work in a safe manner, notifying management of safety issues and risks
• Involve in hands-on execution of the plant operations and assist Supervisors in trouble-shooting
• Actively participate in continuous improvement initiatives
• Perform components staging for autoclaving and parts washer
• Perform assembly and disassembly of process equipment
• Perform parts washer operation as per SOPs
• Perform loading and Operating of Autoclave
• Responsible for MFR (Manufacturing Formulation Record)/SOP creation and revision
• Perform monitoring for process and equipment performance during operation as per SOP/MFR, identify and report if there’s any atypical events
• Support investigation to event and deviation
• Interface with other departments to resolve issues related to daily operations
• Actively support transfer of new processes and commission/validation of new projects
• Actively support Change Control management
The individual will manage equipment and support facility related projects by
• Support routine safety and GMP walk down and responding to findings (If required)
• Support execution of Corrective/Preventive actions which identified (If required)
• Support change control activities which assigned (If required)
• Act as a SME for investigation and solution
• Liaise with other department for Corrective/Preventive actions which identified
• Support shift change/handover activities
Staff Technical Training and Development
• Meet and maintain training requirements
• Complete assigned training on time
• Provide technical training for area personnel
• Provide input on training material development
• Deputize for shift supervisor’s activities
• Provide annual performance self-assessment on development plan
• Responsibility to adhere to any applicable EHS requirements.
• Commitment to a fair and respectful relationship to others and behavior in accordance with Code of Conduct.
Role 3: Microbiology Medical Technologist
• Determine normal and abnormal components of body fluids by conducting chemical analyses of blood, urine, spinal fluids, and gastric juices.
• Analyze blood cells by counting and identifying cells, using microscopic techniques and procedures.
• Prepare blood, plasma, and platelets for transfusions by conducting blood group, type, and compatibility tests.
• Ensure operation of analyzers, spectrophotometers, colorimeters, flame photometers, and other laboratory equipment by calibrating; completing preventive maintenance requirements; following manufacturer's instructions; troubleshooting malfunctions; calling for repairs; maintaining equipment inventories; evaluating new equipment and techniques.
• Maintain laboratory supplies inventory by checking stock to determine inventory level; anticipating needed supplies; placing and expediting orders for supplies; verifying receipt of supplies.
• Conserve laboratory resources by using equipment and supplies as needed to accomplish job results.
• Provides medical technology information by answering questions and requests.
• Prepare reports of technological findings by collecting, analyzing, and summarizing information.
• Maintain professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; participating in professional societies.
• Maintain inter- and intradepartmental work flow by fostering a spirit of cooperation.
• Maintain safe and clean working environment by complying with procedures, rules, and regulations.
• Protect patients and employees by adhering to infection-control and hazardous waste policies and protocols; following identification procedures.
• Maintain patient confidence and protects the hospital by keeping information confidential.
• Contribute to team effort by accomplishing related results as needed.
• Min BSc in Biomedical Science, BSc in Chemical Engineering, BSc in Biotechnology or BSc in a related Science field and/or equivalent experience
• Willing to learn, positive attitude and must be a teamplayer
• Salary commensurate with experience
If you are interested in the position, do kindly drop your most updated resume to [Click Here to Email Your Resume] (Attn: QO/ Biotech/ Med Tech - Leon)
Leon Leong De Cong
Recruit Express Pte Ltd (Healthcare & Lifesciences Division)
EA License: 99C4599
Recruit Express Pte Ltd