Description
Job Summary:

The Quality Control (QC) Specialist will be responsible for ensuring the quality and compliance of pharmaceutical development study protocols and reports. This role involves the review and approval of documentation related to the development process, acting as a subject matter expert (SME) in the QC function, and coordinating with Contract Manufacturing Organizations (CMOs) to investigate deviations related to testing protocols. The ideal candidate will have extensive experience in quality control within the pharmaceutical industry, with solid analytical skills and a deep understanding of regulatory standards.

Key Responsibilities:
- Review and Approval of Study Protocols and Reports:
- Review and approve pharmaceutical development study protocols, ensuring they meet regulatory requirements and company quality standards.
- Critically evaluate study reports to ensure data accuracy, completeness, and compliance with established protocols and industry standards.
- Collaborate with cross-functional teams, including R&D;, Quality Assurance, Regulatory Affairs,



and Manufacturing, to address any discrepancies or concerns identified during the review process.
- Quality Control Subject Matter Expert (SME):
- Act as the SME for the QC function, providing guidance and expertise on quality control best practices, methodologies, and regulatory requirements.
- Lead and support the development and implementation of QC processes, procedures, and standards to ensure consistent quality across all pharmaceutical development activities.
- Provide technical support and training to QC personnel and other stakeholders on QC principles, techniques, and regulatory expectations.
- Regulatory Compliance:
- Ensure all reviewed and approved documents comply with applicable regulatory requirements, including FDA, EMA, ICH, and other global standards.
- Stay current with changes in regulatory requirements and industry best practices, ensuring that study protocols and re

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