Validation Specialist

Symbiotica Speciality Ingredients Sdn Bhd; Seberang Perai; On-site; MYR 50,000 - 70,000; Full time

Job summary

A leading company in the production of steroidal Active Pharmaceutical Ingredients in Malaysia is seeking an Analytical Validation Specialist. This full-time on-site role involves ensuring high-quality standards through various validation activities, method development, and supporting continuous quality improvement initiatives. Candidates should possess a Bachelor's degree in a relevant scientific field and have a strong background in quality control tools and processes.

Qualifications

• Strong understanding of ICH Q2R2 & ICH Q14.
• Experience in the pharmaceutical industry preferred.

Responsibilities

• Plan, execute, and document validation activities.
• Conduct validation tests and analyze results.
• Maintain compliance with regulatory standards.

Skills

Method Development

Analytical Method Validation

Analytical Skills

Attention to Detail

Communication Skills

Education

Bachelor's degree in Pharmaceuticals, Chemistry, Biotechnology, or related field

Tools

HPLC

LCMS

GC-HS

Laser Diffraction Particle Size Analyser

Job description

Company Description

Symbiotica Speciality Ingredients Sdn Bhd is a leading company in the production of complex steroidal Active Pharmaceutical Ingredients (APIs). Our vision is to be at the forefront of delivering high-quality APIs that improve health and well-being worldwide. We are committed to excellence and innovation in the pharmaceutical industry, ensuring our products meet the highest standards.

Role Description

This is a full-time on-site role for an Analytical Validation Specialist at our Quality Control Department located in Kulim, Kedah, Malaysia. The Validation Specialist will be responsible for planning, executing, and documenting various validation activities including Analytical Method Validation, Method Development, method verification, computer system validation, analytical aspects of process validation/ cleaning validation and ensuring adherence to quality control and quality assurance protocols. Daily tasks involve conducting validation tests, analyzing results, maintaining compliance with regulatory standards, and supporting quality improvement initiatives.

Qualifications

• Skills in method development and analytical method Validation & verification as per Pharmacopoeia.
• Expertise in Quality Control instruments such as HPLC, LCMS, Fraction collection, GC-HS, laser diffraction particle size analyser ( Malvern ) eyc
• Strong understanding and experience in validation management and guidelines such as ICH Q2R2 & ICH Q14.
• Excellent attention to detail and analytical skills
• Good written and verbal communication skills
• Bachelor's degree in Pharmaceuticals, Chemistry, Biotechnology, or related field
• Experience in the pharmaceutical industry is a plus especially in Active pharmaceutical industry.
• Ability to work independently and as part of a team