QC Analyst (Sample Handling/ GMP/ BioTech/ Pharma)
Duration: 12 Months Contract
Location: Tuas
Our client is a fully integrated, global immunotherapy powerhouse who have been working on automated and digitized processes and build continuously capabilities for specialized manufacturing, either for individualized vaccines or for large-scale products like COVID-19 vaccine.
Job Summary:
- Responsible for performing laboratory specific activities, such as sampling, sample administration and simple analytical testing, laboratory supplies inventory control.
Responsibilities:
- Clean Room and Clean Utility sampling and testing
- Incoming raw material sampling and identification testing as per sampling plan and testing plan.
- Sample management for all QC laboratories including receiving, labelling and safely storing samples to be tested. Arrange sample shipment to external testing laboratories.
- GMP-compliant and on time completion documentation of sample administration and analyses and the associated activities as required by method SOPs, control regulations, QC planning documentation, and pharmacopoeia.
- Enters analysis results into the SAP/LIMS system, stores and archives source data and ensures data integrity for the assigned work, permanently monitors assigned analysis methods, including trend controls of data.
- Maintains and calibrates analysis equipment with associated documentation, assists qualifications of analytical equipment with associated documentation and schedule control.
- Promptly informs the laboratory manager about nonconforming analysis values or exceeded limit values, and initiates and processes non-conformance reports (non-conformances and OOx)
- Assists with preparing reports and with drafting and revising test procedures and SOP’s.
- Assists and trains new employees/trainees
- Performs all assigned activities while observing all internal and regulatory requirements (safety and quality)
Requirements:
- Diploma or equivalent with experience in the pharmaceutical sector or comparable qualification with multiyear professional experience in a quality control function sciences
- At least 5 years of industry experience in an analytical, cGMP-regulated environment
- High degree of conscientiousness and diligence (documentation, order and cleanliness at the workstation)
- Sense of ownership and honesty (proactive handling of errors)
Lim Pey Chyi (Apple) - [email protected]
Recruitment Consultant (R2090579)
Manpower Staffing Services (S) Pte Ltd
EA Licence: 02C3423
