Roles & Responsibilities
POSITION SUMMARY
This role is responsible for ensuring the laboratory operations in accordance to ISO 17025 and cGMP
requirements. He / She will serve as analytical lead in variety of projects which includes but not
limited to method validation, method transfer, customized testing activities. In addition, this
individual is responsible for directing the day-to-day project activity through interaction with
technical personnel while gathering, analyzing and interpreting scientific data. He / She must ensure
accurate and precise results are being achieved and properly reported.
DUTIES & RESPONSIBILTIES
- 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 testsEvaluates analytical results to form interpretations of data and renders scientific opinions forclient-driven projects
Serves as subject matter expert (SME) in area of specialization, established standards forregulatory compliance
Serves as technical liaison with Customers with regards to technical services and performsCustomer 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 requirementsProvides problem-solving skills for test procedures and investigations within laboratory unitResponsible for notifying Quality Assurance and Senior Management of any compliancedeficiencies or concerns in a timely manner
Monitors all proficiency-based testing and ensures complianceParticipates in internal Quality Audits, System Audits, Audits conducted by external agenciesand Regulatory Authorities
Participates in quarterly management reviewDrives process, quality and safety improvement initiatives within the departmentJob Description : Senior Analyst
Provides coaching and mentoring to Technical personnelSupports the Laboratory Manager in all relevant functionsGeneral requirements
Maintains confidentiality of all Client information according to internal SOPs, Quality ServiceAgreements, and regulatory requirements.
Actively seeks improvement within area of responsibility and takes necessary action toimplement such improvements.
Adheres to Company Policies and Procedures, including Code of Ethics and to Health and Safetyrequirements.
Performs all other related duties as assigned.QUALIFICATIONS :
Bachelor of Science or any related field; MSc. preferred but not essentialMinimum 2-6 years of relevant QC microbiological experience working in an ISO17025 / GMPlaboratory environment
Experience in method validation and development, method transfer, qualification activities inregulated laboratory
Good knowledge of ISO 17025, cGMP and other regulatory guidelinesGood understanding / working knowledge of Project Management and MeasurementUncertainty (MU)
Good technical understanding and judgementGood interpersonal and communication skills across culturesTeam player with ability to work in cross-functional teams as well as independently dependingon requirement of task on hand
Please submit resumes to john@oaktree.com.sg
Position applying forCurrent remunerationExpected remunerationNotice periodJohn Goh Meng Chye
EA License No : 06C4642
EA Reg No : R1102621
We regret that only shortlisted candidates will be notified.
Tell employers what skills you have
Sampling
Preventive Maintenance
Troubleshooting
Quality Control
Base Metals
Quality Assurance
Quality Improvement
ISO
Research and Development
Chemistry
Interpreting
Compliance
Audits
Molecular Biology
Publications
Laboratory
Calibration