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The PositionPart of the Microbiology/ Environmental Monitoring (EM) team responsible for the following:
Test EM / product stream samples to meet release timelines, in accordance with cGMP regulations and Roche standards.
Support manufacturing operations with 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.
Support investigations of microbial contamination in production processes, classified environments and critical utility systems.
Ensure test methods and data are generated in a cGMP, compliant manner.
The Opportunity:
Technical:
Understand basic microbiological principles (Bioburden, LAL, plating and counting techniques, etc) and execution of intermediate techniques (DET, AET)
Test and review routine and non-routine environmental, raw material, product related samples in accordance to the Standard Operating Procedures (SOP) and Test Methods (TM).
Perform EM, including HVAC/ BSC/ HLFH/ VLFH sampling, fingertips monitoring, compressed gases and water/ clean steam sampling in accordance to cGMP procedures.
Document and review results in the Laboratory Information Management System (LIMS) and/ or documents in accordance to cGMP procedures.
Review routine data and logbooks.
Prepare trend graph for product lot release and trend data analysis.
Functional:
Perform sample receipt, Chain of Custody and storage of QC samples.
Manage life-cycle process for retain and reserve/ reference samples.
Managed and prepare shipment of samples to Receiving labs.
General lab support including housekeeping, document archival, maintaining logbooks and inventory of lab supplies, etc.
Initiate discrepancy record.
Ensuring timely completion of training required to support/ perform cGMP activities.
Raise Work Notifications, follow-up on planned receipt, delivery orders, invoices, etc.
Participate in process improvement works.
Contribute to continuous improvement of laboratory procedures and processes to ensure compliance to cGMPs.
Participates in internal/ external audits and regulatory inspections.
Teamwork:
Cooperates with the Head of Microbiology Operations, QC Ops Lead and teammates to create an environment with strong team spirit.
Strive towards team's objectives/goals.
Demonstrates initiative and proactively turn ideas into action — to make things happen.
Engage in proactive measures to promote a positive safety culture and follows applicable Safety, Health and Environment requirements.
Embody PT behaviors, lean principles and methods while fostering a continuous improvement mindset.
Good team player with 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.
Observe all RSTO's site security measures at all times.
Lean Production System:
Embody PT Lean Production System (LPS), with a continuous improvement mindset and behaviors.
Who You are
Entry Level, Diploma in Microbiology, Biology, Biochemistry or equivalent, or GCE 'A' Levels (Science) with little or no prior relevant work experience.
cGMP standards and laboratory safety procedures
A collaborative and proactive team player
Good verbal and written communication skills in English
Preferred
Willing to work at Singapore Tuas Bay Link (Company shuttle bus is provided).
Must be able to work weekends, off-shifts and overtime as required.
Who we are
A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.
Let’s build a healthier future, together.
Roche is an Equal Opportunity Employer.
