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

📌 QA Executive (Cuddalore)
🏢 Pivot Path Private
📍 Cuddalore