API Quality Control Chemist

Orchid Pharma

Website: orchidpharma.com
Job details:

Key Responsibilities:

• Perform routine and non-routine analysis of API samples, intermediates, and raw materials.
• Conduct analytical testing using instruments such as HPLC, GC, UV-Vis spectrophotometer, IR, and wet chemistry techniques.
• Ensure compliance with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and regulatory requirements (e.g., USFDA, EMA).
• Prepare and standardize reagents, solutions, and volumetric solutions.
• Maintain and calibrate laboratory instruments as per SOPs.
• Document analytical results accurately in laboratory notebooks and electronic systems.
• Review and interpret analytical data, including chromatograms and spectra.
• Investigate out-of-specification (OOS) and out-of-trend (OOT) results.
• Assist in method validation, method transfer, and verification activities.
• Ensure proper handling, storage, and disposal of chemicals and samples.
• Support audits and inspections by regulatory authorities.
• Maintain cleanliness and safety in the laboratory environment.

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