Assistant Quality Analyst

Role & responsibilities

The Quality Control Chemist is responsible for ensuring that all raw materials, in-process materials, finished products, purified water, packaging materials, and environmental samples meet the required quality standards and regulatory requirements. The role involves performing analytical testing, operating laboratory instruments, maintaining GMP-compliant documentation, supporting investigations, and ensuring compliance, GMP and applicable medical device and pharmaceutical regulations.

Roles & Responsibilities:

Perform sampling and analysis of raw materials, chemicals, salts, excipients, and packaging materials.

• Verify compliance with approved specifications and pharmacopeial standards (IP, USP, BP, EP where applicable).
• Release or reject raw materials based on analytical results.
• Conduct routine in-process testing during manufacturing.
• Monitor critical quality parameters of dialysis concentrates and consumables.
• Coordinate with Production to ensure process compliance and product quality.
• Perform testing of finished dialysis consumables before batch release.
• Ensure compliance with approved specifications.

Preferred candidate profile

Qualification

• B.Sc./M.Sc. in Chemistry, Analytical Chemistry, Pharmaceutical Chemistry, or a related science discipline.

• Experience

3-5 years of Quality Control experience in pharmaceutical manufacturing.

Required Skills

• Strong knowledge of GMP, GLP, GDP, and laboratory safety
• Familiarity with ISO 13485 requirements for medical devices.
• Documentation accuracy
• Time management
• Having good knowledge of Laboratory Instrument Operation