Job Summary

The Assistant Manager Quality Assurance will be responsible for overseeing qualification and validation activities, calibration compliance, investigation of OOS/OOT results, and effective implementation of CAPA systems. The role ensures compliance with cGMP requirements, regulatory expectations, and internal quality standards within the API manufacturing facility.

Key Responsibilities

- Review, approve, and monitor equipment qualification and validation activities, including IQ, OQ, PQ, process validation, cleaning validation, and computerized system validation, as applicable.
- Ensure timely planning, execution, and review of calibration activities for instruments and equipment.
- Lead and coordinate investigations related to Out of Specification (OOS) and Out of Trend (OOT) results to identify root causes and ensure closure within defined timelines.
- Review investigation reports and ensure implementation of appropriate corrective and preventive actions (CAPA).
- Monitor CAPA effectiveness and track completion to prevent recurrence of quality issues.
- Ensure compliance with cGMP, data integrity requirements, SOPs, and regulatory guidelines.
- Support internal audits, customer audits, and regulatory inspections by providing required documentation and responses.
- Review and approve quality documents,



protocols, reports, and change controls related to validation and calibration activities.
- Coordinate with Production, QC, Engineering, and other cross-functional teams to ensure timely resolution of quality events.
- Analyze quality trends and identify opportunities for continuous improvement.
- Conduct training programs for employees on investigation processes, CAPA, validation, and quality systems. Required Skills
- Solid knowledge of qualification and validation practices in API manufacturing.
- Expertise in calibration systems and instrument compliance.
- Hands-on experience in handling OOS, OOT investigations, root cause analysis, and CAPA management.
- Thorough understanding of cGMP, ICH guidelines, data integrity, and regulatory requirements.
- Good analytical, documentation, leadership, and communication skills.
- Experience in facing and supporting regulatory audits such as USFDA, EU-GMP, MHRA, or other international inspections.

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 Assistant Manager (Vijayawada)
🏢 Hetero
📍 Vijayawada