Assistant Analytical Technical Service Manager

Position: Assistant Analytical Technical Service Manager

Job Location: Cheng, Melaka, Malaysia

Duties and Responsibilities:

• To lead the key focus areas (stated above) as designated, in terms of analytical activities planning and scheduling, and cross-functional communication.
• To lead Analytical method development & validation for new raw material, packaging, and product (NPD) for both in-house developed or technical transfer, reformulation, and cleaning validation.
• To lead analytical method development of new parameters and improvements for commercialized products.
• To lead impurity analysis to fulfill ICH M7 and ICH Q3 requirements.
• To lead method validation and verification, with complete documentation, following ICH Q2 requirements.
• To lead analytical method transfer to and out of Quality Control.
• To lead investigation reports for Out-of-Specification and Out-of-Trend analytical results (including equipment troubleshooting), and support regulatory correspondence to support the company in any regulatory correspondence with regard to technical aspects (not limited to timely post-market surveillance QC support and report readiness for regulatory submission).
• To lead and manage routine testing (not limited to IUSS, SS, CDP, investigations, and QC for Starting Materials) for IMP.
• To lead the Analytical Method Lifecycle for Finished Products and Raw Materials (including method assessment, planning, and execution of Analytical Method Validation masterplan based on the New Product pipeline, Regulatory Affairs request, and/or Quality Assurance requirement).
• To lead cleaning validation from the Production Technical Services Team.
• To lead change control in the chemical laboratory and updates of relevant laboratory documents (not limited to Standard Operating Procedures, Master lists, Work Instructions and Specifications, Analytical Datasheets, and Analytical Report-Certificate of Analysis templates).
• To support Digital Enabled Laboratory projects, including template generations, data migrations, Computerized Software Validation (CSV), and qualification of electronic systems.
• Ensure all equipment (not limited to Dissolution Apparatuses, LCMS, HPLC units, and balances) are maintained/calibrated/verified on a regular basis to give satisfactory performance.
• To maintain reference standards, chemical and consumables inventory, including sourcing, for daily operations.
• To lead in column management, from sourcing, and maintenance to usage tracking to comply with the documented procedure.
• To propose outsourced external laboratories’ evaluation, selection, qualification, and maintenance.
• To manage outsourced testing, including sample collections, deliveries, and testing completion to ensure timely analysis.
• To ensure all chemists, laboratory technicians, and trainees are trained and qualified to carry out their duties.
• To plan, supervise, and monitor progress on analytical testing assigned to technicians or analysts.
• To highlight any safety concerns in the laboratories to Managers.
• To support the Analytical Technical Service Manager in ensuring laboratory adherence to Good Laboratory Practices and MS ISO/IEC 17025 (including participation in self-inspections / audits to assure conformity to ISO and GMP/GLP).
• To drive the alertness and readiness on data integrity ALCOA plus in the laboratory (not limited to checking logbooks, raw data, and records for accuracy and completeness, software backup, and retrieval activities).
• To lead proactive improvement discussions on methods, procedures, practices, and systems in the laboratory.

Minimum Requirements:

• A Master’s Degree or Doctorate in Chemistry or Science or other relevant fields (preferred).
• At least 3 years of relevant experience as a chemist, familiar with either liquid chromatography, gas chromatography, or mass spectrometry equipment.
• Membership/Licentiateship of the Malaysian Institute of Chemistry or equivalent (preferred).
• Able to work overtime including weekends when necessary.
• Good communication and ability to work in a team environment.