Senior QA Compliance Specialist
Abbott
Date: 4 days ago
City: Karachi
Contract type: Full time
Job Summary
Oversee all quality-related aspects of actual and potential deviations or non-conformances in line with Abbott Policies, AQ, EQDs, SOPs, GMP, the Drug Act, and GxP requirements. Routine GEMBA’s for inspection readiness and to ensure that observations are appropriately documented and CAPAs are established. Identify emerging Quality risks across all functions, trends analyze type of observation and reported through Gemba walks and help functions understand root cause.
Major Responsibilities
Oversee all quality-related aspects of actual and potential deviations or non-conformances in line with Abbott Policies, AQ, EQDs, SOPs, GMP, the Drug Act, and GxP requirements. Routine GEMBA’s for inspection readiness and to ensure that observations are appropriately documented and CAPAs are established. Identify emerging Quality risks across all functions, trends analyze type of observation and reported through Gemba walks and help functions understand root cause.
Major Responsibilities
- Maintain an inspection readiness program to ensure compliance with Abbott policies, cGMP and other regulatory requirements and ensure preparedness for audits and inspections
- Trend analysis of observations, identify root causes and mitigate impact on product/ process quality in line with cGMP requirements
- Participate in Quality risk management program; identify new risks, provide risk assessment on product/ process through cross functional activities
- Provide training and guidance to team members on compliance-related matters to promote a culture of compliance throughout the organization
- Identify opportunities to improve process and communications to strengthen DI controls over data vulnerabilities for 100% DI compliance culture at site
- Comply and ensure compliance to GMP (Good Manufacturing Practices), Quality and other related policies, guidelines, and requirements as applicable by law and Abbott corporate guidelines
- Comply and ensure compliance environment, health and safety policies, guidelines, and requirement as applicable by law and Abbott corporate Guidelines
- Science Graduate/Master; preferably Chemist/Pharm D
- Minimum 3-4 years’ experience in QA and Compliance
- Knowledge of QA In-process, compliance, regulations, and documentation
- Knowledge of technical problem resolution and other all activities taking place in QA operations
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