As part of the Micro/EM Team, you will be responsible but not limited to the following:
- Performance of testing of EM / product stream samples to meet product release timelines and in accordance with cGMP regulations and Roche/Genentech standards.
- Support manufacturing operations by timely completion of testing and disposition.
- Continuous improvement of processes and technology, in collaboration with ASAT, to drive right first time and efficiencies.
- Qualification and validation of test methods.
- Supporting investigations of microbial contamination in production processes, classified environments, and critical utility systems.
- Ensuring test methods and data are generated in a compliant manner following cGMPs.
Key Responsibilities
Technical and Functional:
- Testing and review of routine and non-routine environmental, raw material, product related samples in accordance to the Standard Operating Procedures (SOP) and Test Methods (TM).
- Perform EM which includes HVAC / BSC / HLFH / VLFH sampling, fingertips monitoring, compressed gases and water / clean steam sampling in accordance to cGMP procedures when required.
- Documentation and review of results in the Laboratory Information Management System (LIMS) and/or documents in accordance with cGMP Procedures.
- Prepare EM reports / trend graph for product lot release and trend data analysis.
- Review routine data and logbooks.
- General lab support including housekeeping, equipment maintenance, document archival, maintaining logbooks and inventory of lab supplies, etc.
- Problem solving of testing related issues as well as troubleshooting of equipment.
- Author and/or update existing SOPs, Forms, OJTs and TMs as needed.
- Initiate discrepancy record, perform discrepancy assessment and identify corrective actions where necessary.
- Train other analysts on methods and/or SOP.
- Responsible for ensuring that all training required to support / perform GMP activities are completed timely.
- Participate in internal / external audits and regulatory inspections.
- Raise work notification, g2g shopping cart for purchase of consumables / reagent / media for Lab use. Follow up on the planned receipt, Delivery orders, invoices when required.
- Understanding of basic microbiological principles (bioburden, LAL, plating and counting techniques, etc) and execution of intermediate techniques (DET, AET).
- Participate in project, validation and process improvement works.
- Perform equipment qualification / maintenance, liaise with external / contract lab / vendor.
- Contribute to the continuous improvement of laboratory procedures and processes to ensure compliance to GMPs.
- Provide forecast for consumables / reagent / media used and facilitate in budgeting and financial planning.
- Perform sample receipt and storage of QC samples.
- Manage the life-cycle process for retain and reserve/reference samples.
- Manage and prepare the shipment of samples to Receiving labs.
Leadership:
- Work co-operatively with the Head of Micro/EM and QC Supervisor to create an environment of strong team spirit, timely and effective communications. Strive towards team’s objectives/goals, takes the initiative and proactively turn ideas into action – to make things happen.
- Engage in proactive measures to promote a positive safety culture while ensuring all applicable Safety, Health and Environment requirements are fulfilled in alignment with corporate policy and local legal requirements.
- Embody PT behaviors, lean principles and methods while fostering a continuous improvement mindset throughout the organization by encouraging experimentation and learning.
- A team player and the willingness to cover other colleagues in continued support of the Micro/EM operations.
Safety, Health & Environment:
- Comply with all RSTO’s Safety, Health & Environmental (SHE) requirements, never put oneself and others at safety & health risks, and report any workplace accidents, near misses and hazards as soon as practicable.
- Observe all RSTO’s site security measures at all times, and report any suspicious characters/objects & damaged security mechanisms to Site Security immediately.
Lean Production System:
- Embody PT Lean Production System (LPS), while demonstrating a continuous improvement mindset and behaviors through the use and application of LPS tools for continuous improvement initiatives.
Qualifications
- Degree in Microbiology, Biology, Biochemistry or any Life Sciences discipline or equivalent
- 1-3 years of related working experience for degree holders or equivalent holders with combination of education and relative work experience
- Related working experience in a biotech or pharmaceutical operating environment is a plus
- Knowledge / Skills / Competencies:
−Knowledge of cGMP relevant to the pharmaceutical industry
−Knowledge of laboratory safety procedures
−Able to determine when to escalate issue
−Ability to organize and plan effectively
−Good team player
−Demonstrate excellent verbal and written communication skills in English
