About Client: Client is among the Top 10 Pharmaceutical API Manufacturers in India cater to both domestic and international markets with a diverse portfolio of Active Pharmaceutical Ingredients (APIs).
Roles And Responsibilities:
- Prepare review and maintain QA documents including Validation Master Plan Site Master File Drug Master File Annual Product Quality Review SOPs COAs and audit reports.
- Manage quality system records: issuance numbering storage and control of BPRs analytical records deviations CAPA OOS/OOT change controls and risk assessments.
- Perform IPQA activities
- Review and investigate laboratory incidents deviations market complaints CAPA and non-conformities.
- Ensure compliance with GMP in manufacturing and GLP in laboratory operations.
- Conduct internal audits vendor audits and service provider audits according to schedule.
- Coordinate batch dispatches and follow instructions from the Head of Department.
About Client: Client is among the Top 10 Pharmaceutical API Manufacturers in India cater to both domestic and international markets with a diverse portfolio of Active Pharmaceutical Ingredients (APIs). Roles And Responsibilities: Prepare review and maintain QA documents including Validation Master ...
About Client: Client is among the Top 10 Pharmaceutical API Manufacturers in India cater to both domestic and international markets with a diverse portfolio of Active Pharmaceutical Ingredients (APIs).
Roles And Responsibilities:
- Prepare review and maintain QA documents including Validation Master Plan Site Master File Drug Master File Annual Product Quality Review SOPs COAs and audit reports.
- Manage quality system records: issuance numbering storage and control of BPRs analytical records deviations CAPA OOS/OOT change controls and risk assessments.
- Perform IPQA activities
- Review and investigate laboratory incidents deviations market complaints CAPA and non-conformities.
- Ensure compliance with GMP in manufacturing and GLP in laboratory operations.
- Conduct internal audits vendor audits and service provider audits according to schedule.
- Coordinate batch dispatches and follow instructions from the Head of Department.
View more
View less