QA Batch Release
Posted Updated
Description
Key Responsibilities
Quality Systems Management
- Implemented and maintained the Quality Management System (QMS) ensuring compliance with global regulatory standards.
- Conducted investigations for Deviations, Corrective and Preventive Actions (CAPA), and Market Complaints, ensuring timely root cause analysis and effective preventive measures.
- Initiated, reviewed, and closed Change Controls, Deviations, and CAPA within e-QMS systems.
- Conducted risk assessments and contributed to continual improvement in compliance processes.
- Prepared and reviewed quality documents, SOPs, and reports summarizing trends, findings, and compliance status.
Audit and Compliance
- Monitored IPQA activities, ensuring adherence to cMP standards during in-process stages.
- Coordinated and participated in self-inspections, customer audits, and regulatory inspections, ensuring timely implementation of corrective actions.
- Ensured ongoing regulatory compliance across manufacturing and documentation activities.
- Maintained communication and responses to Drug Authorities and government departments for audit
Validation and Qualification
- Prepared and reviewed Qualification Protocols for URS, FAT, SAT, IQ, OQ, and PQ.
- Supported equipment and process validation including deaning validation and transport validation.
- Ensured equipment and systems met regulatory expectations for performance, safety, and quality.
Training & Development
- Designed and delivered training programs on GMP, GDP, and Data Integrity to enhance employee competence and regulatory awareness.Acted as a certified interal trainer ensuring effective knowledge transfer and consistent quality culture.
- Trained and motivated QA and production teams to achieve operational excellence and compliance consistency.
- Coordinated with Production, QC, and engineering teams for process improvements and operational efficiency.
Manufacturing & Operational Oversight
- Supervised and planned manufacturing operations including granulation, compression, coating. capsule filling, dry syrup filling, and inspection areas.
- Ensured that manufacturing processes complied with approved procedures, process parameters, and quality standards.
- Coordinated with production, QC, and engineering teams for process improvements and operational efficiency.
Quality Assurance & Continuous Improvement
- Created and implemented company-wide quality standards at Loan License sites, ensuring uniform
- Contributed to achieving QA operational objectives by monitoring policies, enforcing SOPs, and ensuring quality compliance.
- Supported budget estimation, resource planning, and financial control for QA activities.
- Conducted hazard analysis and developed quality assurance plans for critical manufacturing and testing processes.
- Led continuous improvement initiatives to optimize QMS effectiveness, reduce errors, and strengthen compliance.