QC (DC) Executive
1 Nos.
117526
Full Time
6.0 Year(s) To 8.0 Year(s)
6.00 LPA TO 9.00 LPA
Pharma / Biotech / Healthcare / Medical / R&D
B.Sc - Bio-Chemistry/Bio-Technology; B.Tech/B.E. - Bio-Chemistry/Bio-Technology; M.Sc / MS Science - Chemistry
Job Description:
Job Title: QA Executive – Quality Systems
Department: Quality Assurance
Location: Vadodara, Gujarat
Reporting To: QA Manager / Head of Quality
Key Responsibilities:
- Quality Management System (QMS):
- Maintain and update the QMS in compliance with GMP and regulatory standards.
- Ensure documentation practices align with GDP (Good Documentation Practices).
- Support implementation and continuous improvement of QMS processes.
- Change Control:
- Review and assess change control requests related to equipment, processes, and documentation.
- Conduct risk assessments and impact analysis for proposed changes.
- Ensure timely closure of change controls with proper documentation and approvals.
- SOP Management:
- Draft, review, and revise Standard Operating Procedures (SOPs) in coordination with relevant departments.
- Ensure SOPs are current, compliant, and effectively implemented.
- Train staff on new or revised SOPs and monitor adherence.
- Audit & Compliance:
- Prepare for and participate in internal and external audits (e.g., USFDA, WHO-GMP, ISO).
- Address audit observations and ensure timely implementation of CAPAs.
- Conduct self-inspections and compliance checks across departments.
- Equipment Qualification & Validation:
- Coordinate and document equipment qualification (IQ/OQ/PQ) and validation activities.
- Ensure calibration and preventive maintenance schedules are followed.
Review validation
Job Title: QA Executive – Quality Systems
Department: Quality Assurance
Location: Vadodara, Gujarat
Reporting To: QA Manager / Head of Quality
Key Responsibilities:
- Quality Management System (QMS):
- Maintain and update the QMS in compliance with GMP and regulatory standards.
- Ensure documentation practices align with GDP (Good Documentation Practices).
- Support implementation and continuous improvement of QMS processes.
- Change Control:
- Review and assess change control requests related to equipment, processes, and documentation.
- Conduct risk assessments and impact analysis for proposed changes.
- Ensure timely closure of change controls with proper documentation and approvals.
- SOP Management:
- Draft, review, and revise Standard Operating Procedures (SOPs) in coordination with relevant departments.
- Ensure SOPs are current, compliant, and effectively implemented.
- Train staff on new or revised SOPs and monitor adherence.
- Audit & Compliance:
- Prepare for and participate in internal and external audits (e.g., USFDA, WHO-GMP, ISO).
- Address audit observations and ensure timely implementation of CAPAs.
- Conduct self-inspections and compliance checks across departments.
- Equipment Qualification & Validation:
- Coordinate and document equipment qualification (IQ/OQ/PQ) and validation activities.
- Ensure calibration and preventive maintenance schedules are followed.
Review validation
Key Skills :
Company Profile
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