Senior Analytical Method Lead - QC & Validation (IMP)

Xepa-Soul Pattinson (Malaysia) Sdn Bhd; Malacca City; On-site; MYR 58,000 - 78,000; Full time

Job summary

A pharmaceutical company located in Malacca is seeking an Analytical Technical Services Chemist / Quality Control Chemist. The ideal candidate will lead analytical method development, conduct impurity analysis, and manage testing for investigational medicinal products. A Master's or Doctorate in Chemistry or a related field is preferred, along with at least two years of experience in chemistry, particularly with chromatography techniques. The role involves adhering to Good Laboratory Practices and requires strong communication skills. Overtime availability is a must.

Qualifications

• 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.

Responsibilities

• Lead analytical method development & validation for new raw material, packaging, and product.
• Lead impurity analysis to fulfill ICH M7 and ICH Q3 requirements.
• Lead method validation and verification with complete documentation.
• Manage routine testing for Investigational Medicinal Product (IMP).
• Support cleaning validation and change control in the chemical laboratory.

Job description

A pharmaceutical company located in Malacca is seeking an Analytical Technical Services Chemist / Quality Control Chemist. The ideal candidate will lead analytical method development, conduct impurity analysis, and manage testing for investigational medicinal products. A Master's or Doctorate in Chemistry or a related field is preferred, along with at least two years of experience in chemistry, particularly with chromatography techniques. The role involves adhering to Good Laboratory Practices and requires strong communication skills. Overtime availability is a must.