Quality Assurance Manager

3 weeks ago


Baddi, India Acme Generics Full time

Responsibilities 1. Cleaning Validation Plan Development: • Develop and maintain the Cleaning Validation Master Plan (CVMP) for the Oral Solid Site, ensuring alignment with regulatory requirements. • Define cleaning procedures, acceptance criteria, and sampling techniques in eCleen and ensure digital work instructions are available and maintained in electronic form for easy access. 2. Execution of Cleaning Validation: • Lead the execution of cleaning validation activities using eCleen for scheduling, tracking, and documentation of all cleaning processes. • Ensure that cleaning validation protocols are created and managed electronically, documenting all parameters, acceptance criteria, and results. 3. Cleaning Verification and Monitoring: • Use eCleen to monitor ongoing cleaning verification activities and ensure validated cleaning processes consistently meet specified parameters. • Review data from cleaning verification stored in eCleen to identify trends and initiate corrective actions if necessary. 4. Digital Work Instructions Management: • Ensure all cleaning procedures and work instructions are digitized and kept up to date in the electronic system for easy retrieval by operators and quality personnel. • Regularly review and update digital work instructions to ensure they reflect current validated processes. 5. Risk Assessment in Cleaning: • Conduct risk assessments for cleaning validation using eCleen to manage high-risk areas where cross-contamination risks exist (e.g., potent compounds). • Document and mitigate risks in the cleaning process, particularly during equipment changeovers. 6. Deviation Management (Cleaning Validation): • Investigate deviations that occur during cleaning validation and track them using eCleen to ensure root cause analysis and corrective actions are completed promptly. • Ensure timely closure of all cleaning-related deviations through the system. 7. Revalidation Scheduling and Execution: • Manage the revalidation schedule for cleaning processes, using eCleen to ensure timely execution after significant changes. • Maintain an electronic revalidation calendar to track upcoming revalidations. 8. Regulatory Compliance and Audit Support: • Ensure cleaning validation activities are audit-ready, with all documentation, including digital work instructions, available for review. • Use eCleen for quick access to cleaning validation reports and ensure they are up to date and compliant. 9. Data Integrity in Cleaning Validation: • Ensure that all cleaning validation data entered in eCleen and other electronic systems follow ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate). • Conduct regular reviews of electronic cleaning validation records for data integrity compliance. Qualifications Bachelor's degree or equivalent experience in Pharmacy 9+ years' relevant work experience Highly organized with excellent attention to detail



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