Our client is one of the world's leading biotechnology company and they are looking for a Senior QC Lab Analyst (1 year contract) to join their team. This person will be reqiured to work on 12 hours rotating day shift.
- Routine environmental, water, raw material and product testing and approvals (e.g. bioburden, endotoxin, qPCR, microbial ID etc.); media, reagent and culture qualification and approvals (e.g. growth promotion, DNA positive controls, bioballs etc.)
- Sample management which may include movement and storage of samples, reconciliation of sample receipt and aliquoting of samples, as well as stability sample management.
- Equipment procurement, installation commissioning and qualification, calibration and maintenenace
- Troubleshooting issues related to testing and equipment
- Involvement in method transfers, method verification and sample type qualification
- Technical study protocols, reports and assessments (e.g trend reports, risk assessments)
- Investigations and CAPAs
- Change controls
- Operational Excellence and continuous improvement projects
- Support regulatory inspections
- Degree holders with 4 years of relevant experience or Diploma holders with 7 years of relevant experience within the pharmaceutical or biopharmaceutical industry, biopharmaceutical production and testing experience preferred.
- Strong knowledge and understanding of GMP pharmaceutical production, pharmaceutical plant operation and associated testing methods.
- Strong technical knowledge in the following QC microbial testing methods and equipment is required: e.g. Bioburden & Microbial Limits Test, Endotoxin, Microbial identification, Growth promotion, Environmental monitoring, Utilities monitoring
- Knowledge in the following QC Microbial Testing techniques is preferred but not mandatory - e.g. Biological indicator testing, qPCR
- Meticulous in assay review and approvals.
- Ability to work well with team mates of varying working styles, and gel the team together
- Ability to preempt issues and disruptions to lab operations and deveop mitigation actions
- Ability to supervise, coach, mentor and/or cross train shift staff within core technical areas
- Good communication skills (technical writing and verbal communication/presentation)
- Ability to manage multiple simultaneous activities in a rapidly changing environment
EA License No. 01C4394 I RCB No. 200007268E EA Reg. No. R1984180