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Sr. Executive - QA

Nitika Pharmaceutical Specialities Pvt. Ltd Hingna, Maharashtra, India · ₹600K/yr

Jun 01
qa Senior (5-10 yrs) Full-time India
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About the role

The Senior Executive will ensure compliance with cGMP, SOPs, and regulatory standards across manufacturing and packaging operations. They are responsible for reviewing quality documentation, managing investigations, and supporting internal and external audits.

What they look for

Quality Assurance cGMP SOPs Documentation Audit Handling Deviation Management CAPA Change Control Batch Release Regulatory Compliance Validation Data Integrity Quality Risk Assessment Pharmaceutical Manufacturing In-process Checks Line Clearance

Requirements

Candidates must hold a B.Pharm, M.Pharm, or M.Sc degree with 4-7 years of experience in the pharmaceutical or healthcare industry. Strong knowledge of quality systems, documentation, and regulatory compliance is required.

Full description

Job Description – Sr. Executive QA

Position: Senior Executive – Quality Assurance

Department: Quality Assurance (QA)

Location: Butibori / Nagpur

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-oriented Senior Executive – Quality Assurance to join our Quality team. The ideal candidate will be responsible for ensuring compliance with cGMP, SOPs, regulatory guidelines, and quality systems across manufacturing and packaging operations. The role requires strong exposure to documentation, audits, investigations, and process compliance.

Key Responsibilities

  • Ensure implementation and compliance of cGMP, GDP, SOPs, and quality standards in manufacturing and packing areas.
  • Review and approve BMR, BPR, logbooks, protocols, reports, and quality documents.
  • Handle deviation, change control, CAPA, incident, and market complaint investigations.
  • Conduct line clearance, in-process checks, and shop floor QA activities.
  • Review and monitor batch release documentation before final disposition.
  • Support internal, external, customer, and regulatory audits.
  • 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 as per regulatory requirements and data integrity norms.

Required Skills

  • Strong knowledge of Quality Assurance systems
  • Good understanding of pharmaceutical GMP guidelines
  • Experience in deviation, CAPA, change control, and audit handling
  • Strong documentation and review skills
  • Good communication and coordination abilities
  • Knowledge of regulatory compliance and validation documentation

Preferred Candidate Profile

  • Experience in pharmaceutical manufacturing plant
  • Exposure to regulated markets / audit compliance
  • Strong analytical and problem-solving skills
  • Team handling and coordination experience preferred

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