Required QA Officer/Sr Officer -Pharma API Co.

Company - Pharma API Co.

Location - Luna /Ekalbara

Experience - 2 to 5 years

Designation - Officer/Sr Officer- QA

Dept - QA

Job Responsibilities:

• Ensure overall cGMP compliance and adherence to SOPs.
• Perform and verify API and saleable intermediates sampling.
• Issue and manage GMP-related documents, including log books, BMRs, ECRs, protocols, and reports.
• Record and review temperature, humidity, and stability chamber data.
• Oversee stability and hold time studies (preparing protocols, reports, sample management).
• Review and prepare analytical documents, certificates of analysis, and method validation reports.
• Manage third-party analysis, deviations, OOS, OOT, and market complaints.
• Conduct equipment qualifications and maintain master equipment/instrument lists.
• Handle change controls, recalls, and sales returns.
• Schedule and manage self-inspections and internal audits.
• Oversee the release or rejection of APIs/saleable intermediates.
• Respond promptly to market queries.