Location:East
Working Hours:Mon – Fri, office hours
Duration: 1 year contract
Salary:Up to $5,000 per month
Job Description:
- Provides strong, independent technical leadership to technical personnel
- Leads, designs and performs method development (i.e. bioassay and mycoplasma) and validation of new test procedures for incoming projects
- Functions as Technical Reviewer for A2LA accredited tests and non-accredited tests
- Evaluates analytical results to form interpretations of data and renders scientific opinions for client-driven projects
- Serves as subject matter expert (SME) in area of specialization, established standards for regulatory compliance
- Serves as technical liaison with Customers with regards to technical services and performs Customer site visits where required
- Prepares documents including methods, procedures, standard operating procedures (SOP), study protocols, summary reports
- Assures that SOPs are in accordance to ISO 17025, cGMP and other regulatory requirements
- Provides problem-solving skills for test procedures and investigations within laboratory unit
- Responsible for notifying Quality Assurance and Senior Management of any compliance deficiencies or concerns in a timely manner
- Monitors all proficiency-based testing and ensures compliance
- Participates in internal Quality Audits, System Audits, Audits conducted by external agencies and Regulatory Authorities
- Participates in quarterly management review
- Drives process, quality and safety improvement initiatives within the department
- Provides coaching and mentoring to Technical personnel
- Supports the Laboratory Manager in all relevant functions
Requirements:
- Bachelor of Science or any related field; MSc. preferred but not essential
- Minimum 2-6 years of relevant QC microbiological experience working in an ISO17025 / GMP laboratory environment
- Experience in method validation and development, method transfer, qualification activities in regulated laboratory
- Good knowledge of ISO 17025, cGMP and other regulatory guidelines
- Good understanding/working knowledge of Project Management and Measurement Uncertainty (MU)
- Singaporeans only