QA Batch Release

Company : Talentxplore

Job Type : Full Time

Derabassi, Punjab

Job Description - QA Batch Release

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.

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