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.
- 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
- 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
- QA-quality Assurance
- Quality Assurance Executive
- Executive Quality Assurance
- Pharmaceutical Quality Assurance Executive
Required Qualifications:
Preferred Skills & Competencies:
Industry:
Pharmaceuticals / API / Formulations
Key Skills
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