Senior AMV Executive — Method Validation & Tech Transfer

NOVUGEN PHARMA (MALAYSIA) SDN. BHD.; Nilai; On-site; MYR 72,000 - 98,000; Full time

Job summary

Novugen Pharma (Malaysia) Sdn. Bhd. in Negeri Sembilan seeks an Executive, Analytical Method Validation to support AMV development, validation and tech transfer for formulations. The role includes preparing dossiers and ensuring compliance with regulatory standards.

You will perform validation activities for assay, dissolution, related substances; maintain documentation, manage instruments, and coordinate with cross-functional teams under supervision.

Qualifications

• Degree in a relevant pharmaceutical discipline.
• Minimum 3 years’ experience in pharma/healthcare industries.
• Experience in Analytical Method Development & Validation technologies.
• Proficient in analytical techniques (HPLC, GC, UV-Vis, dissolution testing).
• Knowledge of regulatory expectations for analytical submissions and data integrity.

Responsibilities

• Shall perform method validation, verification and method transfer of analytical methods.
• Shall prepare protocol and report for analytical method validation, verification and technology transfer.
• Shall execute assay, dissolution, related substances and other physico-chemical tests for drugs.
• Shall qualify or prepare working standards as per the requirement.
• Online documentation of raw data, logbooks and calibrations; ensure SOPs and GLP compliance.
• Maintain chemicals, HPLC/GC columns, reference standards and working standards per SOP.
• Maintain instruments and calibrations/performance verifications per schedules.
• Coordinate with functions to fulfil analytical prerequisites for API and finished product AMV.
• Assist in preparing and reviewing risk assessments and ensure timely approvals.

Skills

Analytical Method Development

Method validation

HPLC

GC

Dissolution testing

ICH/GxP knowledge

Education

Degree in Pharmacy, Pharmaceutical Sciences, Chemistry or equivalent

Job description

Novugen Pharma (Malaysia) Sdn. Bhd. in Negeri Sembilan seeks an Executive, Analytical Method Validation to support AMV development, validation and tech transfer for formulations. The role includes preparing dossiers and ensuring compliance with regulatory standards.

You will perform validation activities for assay, dissolution, related substances; maintain documentation, manage instruments, and coordinate with cross-functional teams under supervision.