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
- 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
