Senior Officer, IPQA

1 day ago

gujarat, India Amneal Full time

DescriptionDescription : 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 - PreferredBachelor Degree, B. Pharma - PreferredExperience:2 to 4 years of experience in IPQA activities in an API manufacturing unitSkills:• 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.QualificationsMaster Degree, M.Sc. Organic Chemistry - PreferredBachelor Degree, B. Pharma  - Preferred

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