Executive - QA

Trikona Pharmaceuticals; Hyderabad; On-site; INR 700,000 - 1,100,000; Full time

Job summary

Trikona Pharmaceuticals is seeking a QA professional to oversee quality systems and ensure compliance across development and commercial batches. You will engage in audits, coordinate with cross-functional teams, and review critical batch documents to ensure regulatory alignment across CMOs.

Key responsibilities include monitoring change controls, deviations, CAPA, market complaints, OOT/OOS, and collaboration with vendors and customers for timely information and documentation.

Responsibilities

• Review of all quality systems i.e Change controls, Deviations, Market complaints, OOT, OOS, CAPA etc.
• To monitor Batch manufacturing at CMOs and review and compliance of the documents as per the requirements.
• To conduct/participate internal quality audits & regulatory / customer audits.
• Communications with External Vendors/customers for relevant information/documents
• Co-ordination with cross-functional teams for meeting schedule timelines for commercial and development activities.
• Review of development and commercial batch documents

Job description

• Review of all quality systems i.e Change controls, Deviations, Market complaints, OOT, OOS, CAPA etc.,
• To monitor Batch manufacturing at CMOs and review and compliance of the documents as per the requirements.
• To conduct/participate internal quality audits & regulatory / customer audits.
• Communications with External Vendors/customers for relevant information/documents
• Co-ordination with cross-functional teams for meeting schedule timelines for commercial and development activities.
• Review of development and commercial batch documents