Job Description

Job Responsibilities:

• Perform qualitative and quantitative chemical analyses using techniques such as HPLC, GC, UV-Vis, FTIR, and titrations.
• Prepare and standardize reagents, solutions, and buffers.
• Conduct testing on raw materials, intermediates, and finished products according to approved methods and SOPs.
• Document all testing activities clearly and accurately in compliance with cGMP and ALCOA+ principles.
• Interpret and evaluate analytical data, ensuring results meet established specifications.
• Participate in method validation, equipment calibration, and troubleshooting as needed.
• Maintain laboratory equipment and ensure proper functioning through routine maintenance and calibration.
• Assist in investigations of OOS (Out of Specification), OOT (Out of Trend), and deviations.
• Collaborate with QA, production, and R&D departments to support manufacturing and product release.

Qualifications:

• Bachelor’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or related field.
• Minimum 2 years of hands-on experience in a QC laboratory within the pharmaceutical or biotech industry.
• Proficient in analytical techniques (e.g., HPLC, GC) and good laboratory practices.
• Solid understanding of cGMP, USP/EP, and FDA regulatory requirements.

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