Search by job, company or skills
Job Scope:
. 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
Job Requirements:
. Min. Degree in any science/ relevant field
. ISO 17025, cGMP and other regulatory guidelines
. Min. 1-2 years relevant experience
For interested applicants, please send your updated resume to: [Confidential Information]
All candidates information will be treated with the strictest confidence
Melissa Zhang Zhiqi (Mezzo)
R2197564
Recruit Express Pte Ltd
99C4599
Date Posted: 04/09/2025
Job ID: 125489389