Senior Chemist

Full Time, onsite
Pharmaniaga LifeScience Sdn Bhd
Puchong, Malaysia

RM 3,000 - RM 4,600 / month

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Job Purpose:

Leading a team of Chemistry Laboratory personnel and operating the laboratory according to the Quality Management System, testing our products to the required quality standards; and fully compliant to regulatory requirements, right first time. To remain impartial to all other pressure from conflict of interest, judgement from financial personnel and shared resources pressure. To keep confidential all information obtained or created during the performance of laboratory activities, except as required by law.

Job Responsibilities:

Responsible for the sampling and analysis of samples; water, starting materials, packaging materials, in-process products, finished products, stability samples and testing of miscellaneous samples (eg: for process equipment performance qualification, cleaning validation) according to approved specifications, test methods and other Quality Control procedures.
To conduct non-viable environmental monitoring of clean rooms (particle) as per procedures.
To write and revise/update Standard Operating Procedures (SOP), Specification, Standards Test Procedures (STP), Testing Procedures (TP) and Work Sheet (WS) for Chemistry Laboratory.
To conduct the required training to laboratory personnel.
To review and correctly report, advice and action on test result/data; to conduct investigation on any occurrence of test result out of specification as per Quality System.
To maintain laboratory record and responsible for safe keeping of all documentations relating to testing eg: preparation and standardization of mobile phase, reagents, volumetric and test solutions.
To purchase the Chemistry Laboratory assets and consumables (CAPEX and OPEX).
To assist on the laboratory equipment qualification (IQ/OQ/PQ).
To check and organize the calibration and maintenance of laboratory equipment.
To involve in analytical method transfer exercise (AMTE) between PRC and PLS Laboratories.
To ensure records of equipment usage and other activities log sheets are updated and reviewed accordingly.
To review analytical methods of new products submitted by PRC (Pharmaniaga Research Centre) laboratory and recommend purchases of necessary equipment, chemical and reference standards where necessary.
To ensure proper segregation, recording and storage of all wastes related to Chemistry Laboratory.
To ensure temperature and relative humidity monitoring in the laboratory, retention room and stability room are conducted and record are updated.
To monitor changes within the regulatory environment and pharmacopoeia requirement with a view to reporting status of the quality systems to the management team and implement new quality initiatives and strategies.
To check and ensure laboratory hygiene and operate to GLP e.g.: cleaning, housekeeping and labeling.
To keep adherence to Good Manufacturing Practice (GMP), ISO 9001, ISO 14000, ISO 45001 and ISO 17025.
To achieve compliance with HALAL requirements, ISO requirements such as ISO 9001, ISO 14000, ISO 45001, ISO 17025, cGMP and GDP requirements such as PIC/S, US-FDA, EU-GMP, EU-GDP, local regulatory and third-party principal requirement.
To deputize Head of Quality Control when required.
Responsible as Laboratory Technical Representative (LTR) to manage the laboratory with respect towards optimization of personnel function and technical operation as per ISO 17025 requirements.
To identifies, develops, and implements improvement of the laboratory measurement capability to meet MS ISO 17025 requirement, department programs and laboratory customer.
Assigns only competent personnel to perform and complete tests.
To deputize the Head of QC to review and approve test result generated by chemical quality laboratory (SM, PM, PPM, FP and Stability), to review and approve in the absence of Head of QC any document pertaining laboratory testing.
To undertake any other duties as directed by the immediate supervisor and Management as and when required.