Description
Job Summary:

The Quality Assurance Specialist will play a critical role in ensuring the quality and compliance of pharmaceutical testing activities. This position is responsible for the review and approval of testing protocols and reports, as well as coordinating with Contract Manufacturing Organizations (CMOs) to oversee investigations related to the execution of testing protocols. The ideal candidate will have a solid background in quality assurance within the pharmaceutical industry, with excellent attention to detail and a deep understanding of regulatory requirements.

Key Responsibilities:
- Review and Approval of Testing Protocols and Reports:
- Review and approve testing protocols, including stability, validation, and method development protocols, ensuring they meet regulatory requirements and company standards.
- Critically evaluate testing reports to ensure the accuracy, completeness, and compliance of data, and to confirm that results align with the objectives of the protocols.
- Collaborate with cross-functional teams, including Quality Control,



Regulatory Affairs, and R&D;, to address any discrepancies or concerns identified during the review process.
- Coordination with Contract Manufacturing Organizations (CMOs):
- Serve as the primary Quality Assurance liaison with CMOs, ensuring that all testing activities are conducted in accordance with approved protocols and regulatory standards.
- Coordinate and oversee investigations related to deviations, non-conformances, or out-of-specification (OOS) results that occur during the execution of testing protocols at CMOs.
- Ensure that CMOs implement appropriate corrective and preventive actions (CAPA) in response to identified issues, and verify the effectiveness of these actions.
- Regulatory Compliance:
- Ensure that all reviewed and approved documents comply with applicable regulatory requirements, including FDA, EMA, and other global standards.
- Stay informed about changes in regulatory requi

📌 QA Specialist (Kukatpally)
🏢 Aveva Drug Delivery Systems
📍 Kukatpally