Purpose:
- Performs functions associated with cGMP manufacturing operations for the Manufacture of clinical and bulk drug substance per safety, regulatory and operational requirements
- Uses sophisticated programs (such as LIMS, SAP, automated control systems, etc.) for executing and monitoring operations
- Complete batch documentation accurately and thoroughly, while adhering to the required quality and safety standards, and in a productive, cost-effective manner.
Key Responsibilities:
Operations & Technical
- Adhere to cGMP and safety requirements
- Ensure good housekeeping of associated production facilities so that they are kept in good operational order
- Identify areas for improvement and participate in continuous improvement projects to enhance operational effectiveness and efficiency
- Participate in commissioning and qualification activities as required
- Carry out other related duties as assigned by the Lead or Supervisor
- Assigned as in-charge by process/operations area to provide guidance/leadership to ensure processes are completed reliably
Training & Development
- Ensure that he/she is trained/qualified in the current effective SOP and OJT in accordance with the assigned training curricula prior to commencing operation.
- Proactively engage N+1 to discuss personal development and follow up on agreed development plan.
- To provide guidance and support to new joiner ensuring his/her smooth transition to the new environment
- To develop oneself as a process SME
- Guide junior employees to ensure knowledge transfer for business continuity.
- Conduct classroom and on-the-job (OJT) training as assigned.
Quality
- Comply with all relevant SOP/Batch record requirements.
- Perform timely review of documentation and make necessary corrections.
- Have good quality mindset and integrity to ensure products are manufactured with the highest quality
- Participate in deviation investigation process (Process, Environmental, Maintenance/Equipment, QC) and implementation of Corrective and Preventive Action (CAPA)
- Participate in cGMP self-inspections to ensure compliance with internal SOPs and regulatory requirements
Reporting & Documentation
- Operate key computer applications related to production function
- Ensure that batch record, checklist and logbooks are correctly recorded, cGMP complied and maintained
- Maintain clear communication with N+1 and fellow colleagues, providing clear feedback of any items pertaining to safety, quality and efficiency
- Participation in development and generation of production checklist, SOPs, validation protocols and the regular review and updates of these documents
- Perform VS review of completed documentation to ensure adherence to GDP
- To lead design/drafting of working instruction to ensure that it is user friendly to improve GDP
Technical Transfer
- Participate in new technology and/or new process transfer
Security/Safety/Environment
- Awareness and adherence to site safety procedure.
- Ensure safe operations on the field
- Identify and report all potential safety issues (personal protection requirement, equipment protection, way of working etc).
- Ensure proper housekeeping of assigned production areas to minimize safety hazards
- Participate in Safety Inspections
- Participate in Workplace Risk Assessment
Interface with cross-functional teams
- Coordination with department colleagues to ensure timely supplies of materials and buffers calibration/maintenance activities are supported.
- Open communication on sampling requirements to QC department
- Establish good working relationship with QA, QC, maintenance, calibration to ensure smooth operations.
Qualifications
- Bachelor's Degree in Science, Engineering or equivalent
- 4+ years of relevant experience working in Biologics Production facility
- Proven problem-solving skills and the ability to adapt to new requirements
- Strong working knowledge of Microsoft and other software packages, SAP, LIMS, Atlas systems preferred
- Experience with cGMP documentation and record maintenance preferred
- Excellent attitude towards work and keen willingness to learn and perform hands-on work
- Excellent team player with strong troubleshooting and analytical skills
- Willingness and ability to perform shift work required
