Key Responsibilities:
- Perform chemical and instrumental analysis (HPLC GC UV FTIR) for raw materials intermediates and finished APIs.
- Prepare review and update SPECs STPs and SOPs ensuring adherence to GMP & GLP regulations.
- Manage QMS documentation including deviations OOS OOT CAPA and ensure compliance with internal and external audits.
- Oversee instrument calibration qualification and maintenance ensuring accuracy and regulatory adherence.
- Support investigations root cause analysis and implementation of corrective and preventive actions.
- Work closely with cross-functional teams to ensure regulatory compliance.
- Assist in regulatory inspections and customer audits maintaining audit readiness at all times.
Requirements:
- Education: . / . in Chemistry Analytical Chemistry or a related field.
- Experience: 6 - 10 years in API Quality Control within the pharmaceutical or chemical industry.
- Skills: Expertise in analytical techniques QMS documentation problem-solving and strong communication.
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