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QA Executive - Pharma

Impact HR n KM Solutions
Posted on
Impact HR n KM Solutions logo

Experience
2 - 8 yrs
Job Location
Nashik, India
Vacancy
1
Designation
QA Executive
Job Type
Not specified

Job Description

Key Responsibilities:
  • Ensure implementation and compliance with cGMP, GLP, GDP, and regulatory guidelines (WHO, USFDA, EU-GMP, Schedule M).
  • Review and approve Batch Manufacturing Records (BMR), Batch Packaging Records (BPR), SOPs, specifications, and protocols.
  • Handle deviations, change controls, OOS/OOT investigations, CAPA, and risk assessments.
  • Monitor in-process quality checks and finished product documentation.
  • Participate in internal, external, and regulatory audits and ensure timely closure of audit observations.
  • Perform and review validation activities including process validation, cleaning validation, and equipment qualification.
  • Control and maintain QA documentation, logs, and quality records.
  • Coordinate with Production, QC, Engineering, and Warehouse teams for quality-related activities.
  • Support product release and market complaint handling.
  • Ensure compliance with data integrity and documentation practices.
  • Required Qualifications:
    • B.Pharm / M.Pharm / B.Sc / M.Sc (Chemistry or related discipline)
    • 1-5 years of experience in Quality Assurance within a pharmaceutical manufacturing environment
    • Strong knowledge of GMP documentation and regulatory compliance
    Preferred Skills & Competencies:
    • Hands-on experience with regulatory audits (WHO / USFDA / MHRA)
    • Knowledge of pharmaceutical quality systems (QMS)
    • Good understanding of validation and qualification procedures
    • Strong analytical, documentation, and problem-solving skills
    • Proficiency in MS Office and quality management systems
    • Good communication and coordination abilities
    Industry:
    Pharmaceuticals / API / Formulations
    Key Skills
    • QA-quality Assurance
    • Quality Assurance Executive
    • Executive Quality Assurance
    • Pharmaceutical Quality Assurance Executive
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