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Senior Lab Analyst(ISO 17025, cGMP, Cell Testing) - D06 Beach Road, High Street, SG

Senior Lab Analyst(ISO 17025, cGMP, Cell Testing) - D06 Beach Road, High Street, SG

OAKTREE CONSULTINGD06 Beach Road, High Street, SG
2 days ago
Job description

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 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 Description : Senior Analyst

  • Provides coaching and mentoring to Technical personnel
  • Supports the Laboratory Manager in all relevant functions
  • General requirements

  • Maintains confidentiality of all Client information according to internal SOPs, Quality Service
  • Agreements, and regulatory requirements.

  • Actively seeks improvement within area of responsibility and takes necessary action to
  • implement such improvements.

  • Adheres to Company Policies and Procedures, including Code of Ethics and to Health and Safety
  • requirements.

  • Performs all other related duties as assigned.
  • QUALIFICATIONS :

  • 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)

  • Good technical understanding and judgement
  • Good interpersonal and communication skills across cultures
  • Team player with ability to work in cross-functional teams as well as independently depending
  • on requirement of task on hand

    Please submit resumes to john@oaktree.com.sg

  • Position applying for
  • Current remuneration
  • Expected remuneration
  • Notice period
  • John 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

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    Lab • D06 Beach Road, High Street, SG

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