Senior Lab Analyst(ISO 17025, cGMP)

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

A2LA accredited tests and non-accredited tests

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

procedures, standard operating procedures (SOP),

study

protocols, summary reports

accordance to ISO 17025, cGMP and other regulatory

requirements

procedures and investigations within laboratory unit

Responsible for notifying Quality Assurance and Senior Management

of any compliance

deficiencies or concerns in a timely

manner

ensures compliance

Audits, System Audits, Audits conducted by external

agencies

and Regulatory Authorities

Participates in quarterly management review

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

all Client information according to internal SOPs, Quality

Service

Agreements, and regulatory

requirements.

responsibility and takes necessary action to

implement

such improvements.

Procedures, including Code of Ethics and to Health and

Safety

requirements.

duties as

assigned.

QUALIFICATIONS :

Bachelor of Science or any related field; MSc. preferred but not

essential

microbiological experience working in an ISO17025 /

GMP

laboratory environment

validation and development, method transfer, qualification

activities in

regulated laboratory

knowledge of ISO 17025, cGMP and other regulatory

guidelines

Project Management and Measurement

Uncertainty

(MU)

judgement

across cultures

cross-functional teams as well as independently

depending

on requirement of task on

hand

Please submit resumes to

john@oaktree.com.sg

for

Expected remuneration

period

John Goh Meng Chye

EA

License No : 06C4642

EA Reg No : R1102621

We regret that only shortlisted

candidates will be notified.