Senior Executive, IPQA

Essential Functions

• Take regular plant rounds to monitor production and ensure compliance with standard operating procedures (SOPs) and GMP.
• Review Batch Manufacturing Records (BMRs), Batch Cleaning Records (BCRs), and analytical records prior to API release.
• Perform sampling of API, intermediates, and KSMs (Key Starting Materials), ensuring cleaning and maintenance of sampling tools.
• Provide line clearance at product changeover and critical process steps.
• Support documentation control activities, ensuring timely filing and retrieval of records.
• Maintain, monitor, and review controlled and retained sample records for intermediates, finished API, and KSMs.
• Ensure adherence to Good Documentation Practices (GDP) and data integrity principles.
• Escalate deviations or discrepancies observed during plant rounds or documentation review.
  

Additional Responsibilities

• Support internal and external audits by providing necessary records and compliance data.
• Assist in preparation and review of SOPs related to IPQA activities.
• Participate in training activities to stay updated with quality and compliance standards.
• Coordinate with QA, QC, and production teams for timely resolution of quality issues.
  

Skills

• Basic knowledge of GMP and cGMP compliance – Intermediate
• In-process Quality Assurance and Line Clearance – Intermediate
• Documentation Control & Review – Intermediate
• Data Integrity & Good Documentation Practices (GDP) – Intermediate
• Sampling Procedures and Sample Management – Intermediate
• Record Management and Compliance – Intermediate
• Team coordination and shop-floor presence – Basic.
  

Education

QUALIFICATIONS

• Master Degree, M. Sc – Organic Chemistry - Preferred
• Bachelor Degree, B. Pharma - Preferred
  

Experience

• 8 years of experience in IPQA activities in an API manufacturing unit