QA Batch Release (Dera Bassi)

QA Batch Release (Dera Bassi)

21 Aug
|
Recognized
|
Dera Bassi

21 Aug

Recognized

Dera Bassi

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.




📌 QA Batch Release (Dera Bassi)
🏢 Recognized
📍 Dera Bassi

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