Pharma Quality Assurance ( Indore)
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Job Location:
Monthly Salary:
Posted on:
22 hours ago
Vacancies:
1 Vacancy
Job Summary
Pharmaceutical Quality Assurance (QA) role ensures drug products meet safety efficacy and regulatory standards by overseeing documentation processes audits and batch release focusing on building quality into manufacturing (cGMP) through activities like SOP review deviation investigation validation and supplier qualification preventing errors rather than just detecting them. Key duties include reviewing batch records (BMRs) managing change controls investigating out-of-specification (OOS) results conducting audits and releasing finished products for distribution all while maintaining compliance with guidelines like GMP GCP GDP.
Core Responsibilities
Document Control: Reviewing and approving Standard Operating Procedures (SOPs) Batch Manufacturing Records (BMRs) and other quality documents.
Batch Record Review: Ensuring manufacturing and packing documents are complete accurate and compliant before product release.
Process Monitoring: Overseeing online checks line clearances and in-process controls during manufacturing.
Audits & Inspections: Conducting internal audits and ensuring readiness for external regulatory inspections.
Deviation & CAPA Management: Investigating deviations OOS results and implementing Corrective and Preventive Actions (CAPA).
Validation: Reviewing and approving validation protocols and reports for processes equipment and cleaning.
Material Control: Approving or rejecting raw materials packaging materials and finished goods.
Training: Providing GMP training to staff.
Key Focus Areas
cGMP Compliance: Ensuring adherence to Good Manufacturing Practices (GMP).
Regulatory Compliance: Staying updated on and implementing relevant pharmaceutical regulations.
Risk Mitigation: Designing processes to prevent quality issues before they occur.
Essential Skills
Strong understanding of pharmaceutical quality systems (CAPA Change Control Audits).
Excellent documentation communication and analytical skills.
Ability to work under pressure and prioritize tasks.
A proactive quality-focused mindset with attention to detail.
Company Industry
IT Services and IT Consulting
Key Skills
- Test Cases
- SQL
- Quality Assurance
- Agile
- TFS
- Jira
- Software Testing
- Test Automation
- Cucumber
- QA/QC
- SDLC
- Selenium
