QC Lab Validation Engineer

2 weeks ago


Singapore Anter Consulting Pte. Ltd. Full time

Responsibilities:

. Support the Quality Control Laboratories with independent, effective and timely testing services and able to ensure that tasks are performed according to requirements with review/verification of results and problem solving for issues identified.

. Responsible for the timely completion and data verification of all testing of raw material, intermediates in-process control samples and final product

. Maintain up-to-date, complete and precise records of all tests performed

. Ensure that all test equipment is used and maintained properly in GMP environment

. Acts as an SME for simple to complex instruments and techniques where needed

. Lead and perform any method transfer or method validation protocols or equipment qualifications and support the transfer of new products

. Understands, implements and maintains cGMP and 6S concept

. Able to present clearly and lead confidently during audits and site leadership inquiries

. Write/revises procedures as necessary and make recommendations for process improvement

. Effectively perform a multitude of laboratory techniques for which they are trained on with minimal error

. Trains new analysts and technicians on all instruments/techniques, as well as routinely reviewing that all

. API lab personnel are adhering to proper GMP standards

. Responsible for assisting the lab supervisor in following up with corrective actions

. Responsible for ownership of laboratory investigation - Able to lead the whole laboratory investigation

. and work alongside with QA for success closure of investigation

. Participate in tier meeting for manufacturing updates on incoming raw materials/in-process samples and final API

. Understands and maintains a safe work environment for themselves and others in accordance with

. procedural requirements by driving all EHS standards, procedures and policies

. Experience with CSV

. Familiar with Lab systems/ equipment qualification


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