Sr. Executive - QA

Zoho; Nagpur District; On-site; INR 600,000 - 900,000; Full time

Job summary

Nitika Pharmaceutical Specialities Pvt. Ltd. in Nagpur (Rural), India, is seeking a Senior Executive – Quality Assurance to join the QA team. You will ensure cGMP compliance, SOP adherence, and regulatory alignment across manufacturing and packaging operations.

The role emphasizes documentation, audits, investigations, and process compliance, with active involvement in CAPA and change control activities.

Qualifications

• Strong knowledge of QA systems and compliance frameworks.
• Solid understanding of pharmaceutical GMP guidelines and audits.
• Experience with deviation, CAPA, change control, and investigations.
• Excellent documentation and review skills for regulated processes.
• Good communication and cross-functional coordination abilities.
• Familiarity with regulatory compliance and validation documentation.

Responsibilities

• Ensure compliance with cGMP, SOPs, regulatory guidelines, and quality systems.
• Review and approve BMR/BPR, logbooks, protocols, reports, and quality documents.
• Handle deviation, change control, CAPA, investigations, and market complaints.
• Conduct line clearance, in-process checks, and shop floor QA activities.
• Monitor batch release documentation before final disposition.
• Support audits from internal, external, customer, and regulatory bodies.
• Prepare and review SOPs, 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 in self-inspection and quality risk assessment activities.
• Maintain documentation per regulatory requirements and data integrity norms.

Skills

Quality Assurance systems

GMP guidelines

Deviation & CAPA

Documentation & review

Communication & coordination

Regulatory compliance & validation

Education

B.Pharm / M.Pharm / M.Sc

Job description

Nitika Pharmaceutical Specialities Pvt. Ltd | Full time

Sr. Executive - QA

Nagpur (Rural), India | Posted on 06/01/2026

Position:Senior Executive – Quality Assurance

Department:Quality Assurance (QA)

Experience:4–7 Years

Industry Preference:Pharma / Healthcare / Manufacturing

Qualification:B.Pharm / M.Pharm / M.Sc

Job Summary

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.

Key Responsibilities

• 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.
  

Required Skills

• 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
  

Preferred Candidate Profile

• Experience inpharmaceutical manufacturing plant
  
• Exposure toregulated markets / audit compliance
  
• Strong analytical and problem-solving skills
  
• Team handling and coordination experience preferred