Posted 2 years ago
For a reputed Organization in API Manufacturing for Raichur (Karnataka) location
Experience required : 12+ Years
Experience in API Quality Assurance is must
Key responsibilities include:
- Approval of :
- SOPs & Formats, Master BPRs, Specifications & Methods of Analysis (MOA), Vendor list, Annual Product quality review (APQR), Validation Master Plan, Site Layouts, P&I Diagrams, Vendor Documents, Validation Protocols & Reports, Quality Risk Assessments, Stability Study Reports, Analytical Method Validation Documents, Environmental Monitoring Summary Reports, Quality Agreements, Internal and External Calibration Schedules, Specimen Signatures, Quality comparison reports
- Investigation, recording findings, review and propose CAPA for the following
- Customer complaints
- Deviations
- Out of specification (OOS) of Raw material, Intermediates and Finished Product
- Incidents
- Non-Conformances (NC)
- Responsible for all mail responses to
- Regulatory authorities
- Customers
- Complaints
- Contract manufacturers
- Review, acceptance, approval of Change Controls
- Conducting internal audits
- Participating in Regulatory Inspections
- To propose and implement corrective and preventive actions (CAPA) for observations made in internal and external audits
- Training to personnel on cGMP systems
- Responsible for Quality Review Meetings (QRM)
- Monitoring of GMP related activities in all departments
- Responsible for Vendor Audits
- Handling of Return Goods
- Handling of Recalls
- Ensure effective functioning of overall Quality Management System (QMS)
- Approve retest dates and extension of retest periods
- Authorize to stop production to ensure resolution of potential quality issues
- Authorized to Release or Reject of finished products
- Authorized to Approve or Reject the raw materials, intermediates and finished products.