Executive Validation

Duopharma Biotech; Selangor; On-site; MYR 60,000 - 80,000; Full time

Job summary

A pharmaceutical manufacturing company in Selangor is seeking a Validation Specialist to execute validation activities and chemical testing. This role involves method validation, documentation management, and coordination to ensure compliance with industry standards. The ideal candidate will have a Bachelor’s Degree in Science, relevant experience in the pharmaceutical sector, and proficiency in laboratory instruments like HPLC and UV-Vis Spectrophotometer. Strong analytical, communication, and documentation skills are essential. This position offers an opportunity to work independently within a regulated environment and contribute to high-quality pharmaceutical production.

Qualifications

• Minimum 3 years of experience in the pharmaceutical industry, preferably in validation.
• Practical experience operating laboratory instruments.
• Ability to work independently in a regulated environment.

Responsibilities

• Execute validation activities including method validation and performance qualification.
• Prepare and maintain validation documentation according to GDP guidelines.
• Coordinate with teams for completion of qualification programs.

Skills

Hands-on experience in Computer System Validation

Strong analytical thinking

Good interpersonal communication skills

Detail-oriented and organized

Proficient in MS Office applications

Education

Bachelor’s Degree in Science or related field

Tools

HPLC

UV-Vis Spectrophotometer

Dissolution Tester

Job description

You will be responsible for executing validation activities and chemical testing in compliance with NPRA standards, GLP guidelines, and other regulatory requirements to support the production of high-quality pharmaceutical products at Duopharma HAPI Sdn Bhd. The role includes performing method validation, qualification activities, stability studies, documentation management, and cross-functional coordination to ensure all validation and testing activities are completed accurately, timely, and in alignment with the Validation Master Plan.

Job Description

You will be responsible for executing validation activities and chemical testing in compliance with NPRA standards, GLP guidelines, and other regulatory requirements to support the production of high-quality pharmaceutical products at Duopharma HAPI Sdn Bhd. The role includes performing method validation, qualification activities, stability studies, documentation management, and cross-functional coordination to ensure all validation and testing activities are completed accurately, timely, and in alignment with the Validation Master Plan.

Key Responsibilities

• Execute validation activities including method validation, performance qualification, periodic evaluation, temperature mapping, cleaning validation, process validation, and computerized system validation as outlined in the Validation Master Plan.
• Prepare, review, and maintain validation documentation in accordance with GDP and Good Documentation Practice guidelines.
• Perform and report testing promptly to support validation and qualification timelines.
• Assist in Technology Transfer activities and support Regulatory Affairs/Pharmacovigilance for product registration requirements.
• Ensure validation, qualification, and stability study activities are conducted in compliance with the latest GLP guidelines.
• Maintain proper documentation and filing of all validation and stability study records.
• Drive continuous improvement initiatives and stay updated with current validation trends and regulatory expectations.
• Coordinate with Engineering, Production, Quality Control, and Quality Assurance teams for the execution and completion of qualification programs.
• Carry out any other duties assigned by the superior.
• Designee: In the absence of the Assistant Manager, Validation, the Senior Technician, Validation, will assume responsibilities for documentation preparation.

Job Requirements

• Bachelor’s Degree in Science or a related field.
• Minimum 3 years of working experience in the pharmaceutical industry, preferably in validation, quality, or laboratory functions.
• Hands‑on experience in Computer System Validation (CSV) and understanding of validation lifecycle activities.
• Practical experience operating analytical laboratory instruments such as HPLC, UV‑Vis Spectrophotometer, Dissolution Tester, etc.
• Proficient in MS Office applications (Word, Excel, PowerPoint).
• Strong analytical thinking with the ability to interpret data and troubleshoot issues effectively.
• Good interpersonal, written, and verbal communication skills with the ability to work across functions.
• Detail‑oriented, organised, and able to manage documentation in compliance with GDP.
• Able to work independently with minimal supervision in a regulated environment while meeting tight project timelines.