Job Description

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:

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