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QA Batch Release

icon building Company : Talentxplore
icon briefcase Job Type : Full Time

Number of Applicants

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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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