-Develop, implement, and maintain an effective Quality Management System for the organization.
-Monitor and evaluate existing QMS processes to identify areas for improvement.
-Conduct internal audits and assessments to ensure compliance with regulatory standards.
-Collaborate with cross-functional teams to establish and maintain quality control measures.
SOP Drafting and Documentation:
- Create, review, and update Standard Operating Procedures (SOPs) related to processes.
- Ensure SOPs are explicit, concise, and aligned with industry best practices.
-Effectively monitor and implement change controls relating to SOPs
Risk Management:
Assist in the development and implementation of strategies to ensure risk management.
Participate in external audits and inspections, as needed.
Perform vendor reviews during onboarding and subsequent reviews.
Data Analysis and Reporting:
-Collect and analyze data related to quality metrics and performance indicators.
-Generate reports and dashboards to track quality performance and trends.
-Identify opportunities for process improvement and make recommendations.
Corrective and Preventive Actions (CAPA):
- Investigate and document non-conformities and incidents.
-Develop and implement corrective and preventive action plans to address issues.
- Monitor the effectiveness of CAPA initiatives and make necessary adjustments.
- Ensure Change Control are actively evaluated and implemented.
Qualifications
Bachelors or Masters in Pharmacy
Candidate Profile
1.5 years of work exp in QA department
Good communication skills
Fluency in English
Pay: ₹300,000.00 - ₹400,000.00 per year
Education:
- Bachelor's (Required)
Experience:
- Quality assurance: 1 year (Required)
Language:
- English (Required)
Work Location: Remote
📌 Senior Executive Quality Assurance (India)
🏢 Genedrift Global Services
📍 India
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