Analytical Chemist

Xepa-Soul Pattinson (Malaysia) Sdn Bhd; Malacca City; On-site; MYR 100,000 - 150,000; Full time

Job summary

A leading company in the pharmaceutical industry is seeking a skilled Chemist to support analytical activities within their Analytical Technical Service Department. The successful candidate will lead method development, validate new raw materials and products, and ensure compliance with various analytical standards. Candidates with a Master's degree or doctorate in Chemistry and at least two years of relevant experience are encouraged to apply.

Qualifications

• Master’s degree or doctorate in Chemistry or Science is preferred.
• At least 2 years of experience as a chemist.
• Familiar with analytical equipment.

Responsibilities

• Lead analytical method development & validation for new raw materials and products.
• Manage routine testing and compliance with ICH guidelines.
• Ensure compliance with Good Laboratory Practices (GLP) and ISO standards.

Skills

Analytical Method Development

Communication

Teamwork

Education

Master’s Degree or Doctorate in Chemistry or Science

Tools

Liquid Chromatography

Gas Chromatography

Mass Spectrometry

Job description

Job Outline:

Responsible for supporting the designated technical activities of the Analytical Technical Service Department.

Focus areas :

1. Product Development – comprises of Analytical Method Development (AMD) and Validation/Verification (AMV), External Liaisons and Analytical Method Transfer (AMT), and Control Strategy from analytical aspects.
2. Compliance – Comprises of Comparative Dissolution Profiling (CDP), Photostability and Stability Study (SS), In-Use Stability Study (IUSS), Maintenance of Analytical Method Lifecycle, Quality Control (QC) of Starting Materials and Certificate of Analysis Generation for Investigational Medicinal Product (IMP).
3. Laboratory Operations – Comprises of Document Management, Digital Enabled Laboratory Project, Consumables Management and Maintenance of Good Laboratory Practice, Personnel Qualification, and Equipment Lifecycle.

Duties and Responsibilities:

1. 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.
2. To lead analytical method development of new parameters and improvements for commercialized product.
3. To lead impurity analysis to fulfill ICH M7 and ICH Q3 requirements.
4. To lead method validation and verification, with complete documentation, following ICH Q2 requirements.
5. To lead analytical method transfer to and out of Quality Control.
6. To lead investigation report 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 regards to technical aspects (not limited to timely post market surveillance QC support and report readiness for regulatory submission).
7. To lead and manage routine testing (not limited to IUSS, SS, CDP, investigations, and QC for Starting Materials) for IMP.
8. To support Analytical Method Lifecycle for Finished Products and Raw Materials (including method assessment, planning and execution of Analytical Method Validation masterplan based on New Product pipeline, Regulatory Affairs request and/or Quality Assurance requirement).
9. To support cleaning validation from the Production Technical Services Team.
10. To support change control in the chemical laboratory and updates of relevant laboratory documents (not limited to Standard Operating Procedures, Masterlists, Work Instructions and Specifications, Analytical Datasheets, Analytical Report-Certificate of Analysis templates).
11. To support Digital Enabled Laboratory projects, including template generations, data migrations, Computerized Software Validation (CSV) and qualification of electronic system.
12. To ensure all equipment (not limited to Dissolution Apparatuses, LCMS, HPLC units, balances) are maintained/calibrated/verified on a regular basis to give satisfactory performance.
13. To maintain reference standard, chemical and consumables inventory, including sourcing, for daily operations.
14. To support in column management, from sourcing, maintenance to usage tracking to comply to the documented procedure.
15. To propose outsourced external laboratories’ evaluation, selection, qualification and maintenance.
16. To manage outsourced testing, including sample collections, deliveries and testing completion to ensure timely analysis.
17. To highlight any safety concern in the laboratories to Managers.
18. To comply to Good Laboratory Practices and MS ISO/IEC 17025 (including participation in self-inspections / audits to assure conformity to ISO and GMP/GLP).
19. To practice 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).
20. To contribute proactively in improvement discussions on methods, procedures, practices, and systems in the laboratory.
21. To assist in other analytical testing when required or any other duties assigned by the Superior.

Minimum Requirements:

• A Master’s Degree or Doctorate in Chemistry or Science or other relevant fields (preferred).
• At least 2 years of relevant experience as a chemist, familiar with either liquid chromatography, gas chromatography and 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 able to work in a team environment.