Senior Officer, IPQA

1 week ago

Ahmedabad, Gujarat, India Amneal Full time ₹ 12,00,000 - ₹ 18,00,000 per year
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:


• 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.

Qualifications

Master Degree, M.Sc. Organic Chemistry - Preferred

Bachelor Degree, B. Pharma  - Preferred


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