Officer, IPQA

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:

• • 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.

Qualifications :-

Education:

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

Experience:

• 2 to 4 years of experience in IPQA activities in an API manufacturing unit

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.

Master Degree, M.Sc. Organic Chemistry - Preferred

Bachelor Degree, B. Pharma  - Preferred