Plant Q.A. Head

Agileibs; North Carolina; On-site; USD 10,000 - 60,000; Full time

Job summary

An established industry player in API manufacturing is seeking a seasoned Quality Assurance professional with over 12 years of experience. This role involves overseeing the quality management system, approving essential documents, and ensuring compliance with regulatory standards. The ideal candidate will be responsible for conducting internal audits, managing customer complaints, and implementing corrective actions to uphold product quality. Join a dynamic team dedicated to maintaining the highest standards in the industry and make a significant impact on product excellence and safety.

Qualifications

• 12+ years of experience in API Quality Assurance is a must.
• Strong understanding of regulatory requirements and quality management systems.

Responsibilities

• Approve and review critical quality documents and processes.
• Conduct internal audits and participate in regulatory inspections.
• Implement corrective and preventive actions for quality issues.

Skills

API Quality Assurance

cGMP systems

Regulatory Compliance

Internal Audits

Job description

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
• 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
• 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.

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OUR ADDRESS

Agile Integrated Business Solutions
SCO 202, City Centre
Amravati Enclave
Panchkula, Haryana, IN