Senior Technician Pharmaceutical Validation

Duopharma Biotech Bhd Group of Companies.; Shah Alam; On-site; MYR 40,000 - 60,000; Full time

Job summary

A leading pharmaceutical firm in Shah Alam is seeking a qualified candidate for a role responsible for executing qualification and validation activities in line with regulatory requirements and company standards. Responsibilities include supporting process validation, conducting testing, and ensuring compliance with GMP and GLP guidelines. The ideal candidate holds a Bachelor of Science in Resource Chemistry and has at least one year of experience in the pharmaceutical industry. Strong analytical and communication skills are necessary, along with hands-on experience with HPLC and Gas Chromatography.

Qualifications

• Minimum 1 year of working experience in the pharmaceutical industry.
• Hands-on experience with HPLC, Gas Chromatography, and Dissolution testing.
• Good knowledge of GMP and GLP requirements.

Responsibilities

• Support and execute process validation activities for new and existing products.
• Perform method validation, performance qualification, and cleaning validation.
• Plan and execute stability programmes and maintain stability study data.

Skills

HPLC

Gas Chromatography

Dissolution testing

Analytical skills

Problem-solving skills

Communication skills

Education

Bachelor of Science (Hons) in Resource Chemistry

Job description

Responsible for executing qualification and validation activities in accordance with the Validation Master Plan to ensure compliance with regulatory requirements, PIC/S Guidelines, and company standards.

Key Responsibilities

• Support and execute process validation activities for new and existing products in compliance with PIC/S Guidelines.
• Perform method validation, performance qualification, periodic evaluation, temperature mapping, cleaning validation, and computerized system validation as per the Validation Master Plan.
• Plan and execute stability programmes and maintain stability study data.
• Conduct testing for validation samples, including Comparative Dissolution Profile (CDP) testing for product registration.
• Coordinate with Production, Quality Control, and Quality Assurance to ensure timely execution and completion of validation activities.
• Prepare, maintain, and ensure proper safekeeping of validation and qualification documentation in accordance with GMP requirements.
• Ensure strict adherence to GMP and GLP practices at all times.
• Perform other duties assigned by the superior to support validation operations.
• Act as designee in the absence of the Executive, including document preparation and related testing activities.

Requirements

• Bachelor of Science (Hons) in Resource Chemistry or related discipline.
• Minimum 1 year of working experience in the pharmaceutical industry.
• Hands-on experience with HPLC, Gas Chromatography, and Dissolution testing.
• Good knowledge of GMP and GLP requirements.
• Strong analytical, problem-solving, and communication skills.
• Highly motivated, result-oriented, and able to work independently as well as in a team.