Job Description
Major activities of work Profile:
- CAPA closure verification Audit of manufacturing Sites (Including sites). Tracking CAPA closure and sustenance. Candidate may have to participate in the supporting role or as an independent auditor (based on Need).
- Supporting senior auditors in new vendor selection desktop audit (site documentation compilation and adequacy review).
- Follow-up with vendors on timely CAPA submission and effective closure by document verification
- Handling Quality Incidents, Deviations, Change management and MIS preparation
Complaint Handling: Liasoning with site and other functions for timely investigation of complaints, supporting site for RCA and CAPA preparation.
Other informations:
- Candidate has to travel to different sites located in different geographical Locations, based on need.
Key Interactions:
This profile interactions with
- Emami site and central purchase team
- Site QA and production tam
- Vendors
- R&D
- Packaging Development team
Work Experience and Knowledge:
- Must have experience of Internal Audit of Manufacturing sites (GMP Schedule M, Schedule T GMP)
- Internal Auditor of ISO 9001: 2015, ISO 2200:2018, FSSAI compliant sites (preferred)
- Basic understanding and experience f applicable regulatory norms of statutory/ regulatory bodies such as PCRO, Weight and measurement Act, FDA, CDSCO, FSSAI and Aayush.
- Basic knowledge and working experience of QA tools such as Change management, Deviation Management, Quality Incidents. Complaint management etc.
- IT skills such as MS office (MS Word, MS Excel, Power point), SAP (preferred)
- Handling Quality Complaints, Quality Incidents and CAPA management