Manager
Job Description
• Logging, review of Market complaints and fulfilments of other market requirements.
• Logging, review of Return Goods and product recall.
• Regulatory Compliances.
• Responsible for customer audit and its responses.
• Review and evaluation of Deviations and CAPA in LIMS.
• Review and evaluation of Out of Specification, NCR etc.
• Review and evaluation of Out of Trend.
• Review and evaluation of Preventive Maintenance in SAP
• Logging and review of Reprocess and Rework.
• Co-ordination with other departments for cGMP compliances.
• Responsible for vendor qualification by vendor audits/their questionnaire and documents.
• Vendor related activities and material management in SAP.
• Preparation & Review of Approved Vendor list.
• Internal Audits.
• Preparation and review of Site Master File (SMF).
• Coordination with local FDA for various FDA related work.