Officer, IPQA

Job Description

Description :

This role involves ensuring real-time monitoring and compliance of production activities in API manufacturing with cGMP standards. The Officer – IPQA is responsible for line clearance, in-process verification, documentation review, and sampling activities. The candidate should possess working knowledge of GMP, data integrity, and documentation practices. This position plays a crucial role in ensuring consistent product quality and adherence to regulatory and internal standards.

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

Qualifications : -

Education

Experience

Skills

Qualifications

Master Degree, M.Sc. Organic Chemistry - Preferred

Skills Required

Sampling Procedures and Sample Management, In-process Quality Assurance and Line Clearance, Documentation Control Review, Basic knowledge of GMP and cGMP compliance, Record Management and Compliance