QA Executive

Role & responsibilities

• Responsible for performing all quality-related documentation in accordance with written approved
  procedures
• Issuance of ECRs and related documents.
• Review of executed BMRs / BPRs/ ECRs and related documents.
• Collection of Data for PQR.
• Issuance of Forms.
• In-Process Monitoring of QA activities
• Coordinating Internal/ Customer and Regulatory audits.
• Review of dispatch CoAs along with supporting data.
• Ensure destruction of obsolete documents from all the departments.
• Issuance of SOPs, SPEC, STP, RoA, Logbooks / Register, Master list, Protocol and Batch records etc., to all
  applicable functions.
• Sharing of SPEC/STP documents to R&D site for impurity qualification purpose
• Creation & updating of Training items.
• Coordinate with users for completion of Annual GXP Refresher training/functional courses.
• Generate periodic reports from LMS for the monthly metrics monitoring.
• Ensuring compliance of cGMP, on the Job training, Classroom training, Document revision training, and Specific
  job training.
• Updating completed training records and Course launch in Learning Management System.
• Job role mapping, Job role matrix, Event form, Training attendance sheet issuance, verification and archival.
• Ensuring Technical training completion.
• Preparation of Validation Protocols and reports.
• Monitoring of Process related validation activities.

Preferred candidate profile