Quality Assurance Manager

1 month ago


Baddi, India Acme Generics Full time
Responsibilities1. 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.QualificationsBachelor's degree or equivalent experience in Pharmacy9+ years' relevant work experienceHighly organized with excellent attention to detail

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