Site Head Quality Assurance
2 weeks ago
Taking care of Quality Assurance function at Dehradun site.
Responsible for All external & internal audits as auditee and maintaining compliance.
Quality Management System, Review of QMS document and give recommendations on the Improvement of the QMS documents and/or the Investigation.
Identify the immerging trends and suggest remediation and improvement plan.
To ensure the compliance of current Good Manufacturing Practices at site and maintaining it in State of control.
Ensure the quality systems are maintained in compliance as per applicable regulatory guidelines. To support all departments for effective implementations of key cGMP initiatives undertaken by various functions and Corporate/ CQU.
To ensure implementation of CAPA's at site.
Batch Disposition: Quality assurance Head has the overall authority to Release or Reject any material and batch/batches of the product.
Responsible to a notification to the management for any critical adverse quality event,
The Site Quality Assurance Head has the authority to recommend a product recall to the MA Holder, Contact Giver and regulatory authority. Recall Notification & Follow up for Product Recall.
Responsible for Validation Management -Process Validation / Cleaning validation / Aseptic process simulation, Audit-Compliance Management, Market complaint/Adverse event Management, PQR Managements, Risk managements, Stability study management, Retention sample management,
To coordinate with QA, QC, RA and Research & development team on Technology Transfer
Requirements.
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