Quality Assurance Manager
3 weeks ago
Acme Generics is seeking a highly organized and detail-oriented Quality Assurance Manager to join our team. As a key member of our quality assurance team, you will be responsible for ensuring the highest standards of quality and compliance in our cleaning validation processes.
Key Responsibilities:- Cleaning Validation Plan Development: Develop and maintain the Cleaning Validation Master Plan (CVMP) for the Oral Solid Site, ensuring alignment with regulatory requirements.
- Execution of Cleaning Validation: Lead the execution of cleaning validation activities using eCleen for scheduling, tracking, and documentation of all cleaning processes.
- Cleaning Verification and Monitoring: Use eCleen to monitor ongoing cleaning verification activities and ensure validated cleaning processes consistently meet specified parameters.
- 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.
- Risk Assessment in Cleaning: Conduct risk assessments for cleaning validation using eCleen to manage high-risk areas where cross-contamination risks exist.
- 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.
- Revalidation Scheduling and Execution: Manage the revalidation schedule for cleaning processes, using eCleen to ensure timely execution after significant changes.
- Regulatory Compliance and Audit Support: Ensure cleaning validation activities are audit-ready, with all documentation, including digital work instructions, available for review.
- Data Integrity in Cleaning Validation: Ensure that all cleaning validation data entered in eCleen and other electronic systems follow ALCOA+ principles.
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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Baddi, Himachal Pradesh, India Acme Generics Full timeJob Title: Quality Assurance ManagerAcme Generics is seeking a highly skilled Quality Assurance Manager to join our team. As a key member of our quality assurance department, you will be responsible for ensuring the highest standards of quality and compliance in our cleaning validation processes.Responsibilities:Cleaning Validation Plan Development:Develop...
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Baddi, Himachal Pradesh, India Acme Generics Full timeJob Title: Quality Assurance ManagerAcme Generics is seeking a highly skilled Quality Assurance Manager to join our team. As a key member of our quality assurance department, you will be responsible for ensuring the highest standards of quality and compliance in our cleaning validation processes.ResponsibilitiesCleaning Validation Plan Development:Develop...
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Baddi, Himachal Pradesh, India Acme Generics Full timeJob Title: Quality Assurance ManagerAcme Generics is seeking a highly skilled Quality Assurance Manager to join our team. The successful candidate will be responsible for ensuring the quality and integrity of our cleaning validation processes.Key Responsibilities:Develop and maintain the Cleaning Validation Master Plan (CVMP) to ensure alignment with...
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