About the role
Department:Quality Assurance (QA)
Location:Butibori / Nagpur
Experience:4–7 Years
Industry Preference:Pharma / Healthcare / Manufacturing
Qualification:B.Pharm / M.Pharm / M.Sc
We are looking for an experienced and detail-orientedSenior Executive – Quality Assuranceto join our Quality team. The ideal candidate will be responsible for ensuring compliance withcGMP, SOPs, regulatory guidelines, and quality systemsacross manufacturing and packaging operations. The role requires strong exposure to documentation, audits, investigations, and process compliance.
- Ensure implementation and compliance ofcGMP, GDP, SOPs, and quality standardsin manufacturing and packing areas.
- Review and approveBMR, BPR, logbooks, protocols, reports, and quality documents.
- Handledeviation, change control, CAPA, incident, and market complaint investigations.
- Conductline clearance, in-process checks, and shop floor QA activities.
- Review and monitorbatch release documentationbefore final disposition.
- Support internal, external, customer, and regulatory audits.
- Prepare and reviewSOPs, validation protocols, qualification documents, and reports.
- Coordinate with Production, QC, Engineering, and Warehouse teams for quality compliance.
- Ensure timely closure of observations, deviations, and CAPAs.
- Participate inself-inspection and quality risk assessment activities.
- Maintain documentation as perregulatory requirements and data integrity norms.
- Strong knowledge ofQuality Assurance systems
- Good understanding ofpharmaceutical GMP guidelines
- Experience indeviation, CAPA, change control, and audit handling
- Strong documentation and review skills
- Good communication and coordination abilities
- Knowledge ofregulatory compliance and validation documentation
- Experience inpharmaceutical manufacturing plant
- Exposure toregulated markets / audit compliance
- Strong analytical and problem-solving skills
- Team handling and coordination experience preferred