Job Purpose:To assist of Bio-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. In addition, hold the responsibility as a deputy for management representative for ISO 17025. To remain impartial to all other pressure from conflict of interest, judgement from financial personnel and shared resources pressure.Job Responsibilities:- To perform sampling and conduct testing of incoming materials (formulation bulk product and excipients), packaging materials (vials, ampoules, rubber closures, flip-off seals, labels, package inserts and printed cartons), finished products and utilities (water, pure steam and nitrogen) according to sampling instructions and other Quality Control procedures.- Responsible for the 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 Bio-Chemistry Laboratory assets and consumables (CAPEX and OPEX).- To assist Senior Bio Chemist on the laboratory equipment qualification (IQ/OQ/PQ).- 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 14001, ISO 18001 and ISO 17025.- To achieve compliance with HALAL requirements, ISO requirements such as ISO 9001, ISO 14001, OHSAS 18001, ISO 17025, cGMP and GDP requirements such as PIC/S, US-FDA, EU-GMP, EU-GDP, local regulatory and third-party principal requirement.- 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 quality control laboratory (SM, PM, PPM, FP and Stability), to review and approve in the absence of Head of QC any document pertaining laboratories.- To undertake any other duties as directed by immediate supervisor and Management as and when required.- To check and organize the calibration and maintenance of laboratory equipment's.- To involve in analytical method transfer exercise (AMTE) between technical partner 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 technical partner 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 Bio-Chemistry Laboratory.- To ensure temperature and relative humidity monitoring in the laboratory, retention room and stability**Job Types**: Full-time, Permanent**Salary**: RM3,000.00 - RM4,600.00 per month**Benefits**:- Dental insurance- Health insurance- Maternity leave- Parental leaveSchedule:- Monday to FridayAbility to commute/relocate:- Puchong: Reliably commute or planning to relocate before starting work (required)
