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 strong 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 reports are updated accordingly.
- Support regulatory submissions by providing QC-related documentation and expertise as required.
- Coordination with Contract Manufacturing Organizations (CMOs):
- Work closely with CMOs’ Quality Control units to ensure that all testing activities are conducted in accordance with approved protocols and regulatory standards.
- Investigate and resolve any deviations to testing protocols that occur at CMOs, ensuring a thorough understanding of the root cause and the implementation of corrective and preventive actions (CAPA).
- Monitor and follow up on the effectiveness of CAPA implemented by CMOs to ensure continuous compliance and quality improvement.
- Continuous Improvement:
- Identify opportunities for process improvements in the QC review and approval process, and implement changes to enhance efficiency and effectiveness.
- Participate in internal audits and contribute to the development and refinement of standard operating procedures (SOPs) related to QC activities.
- Lead or support quality improvement initiatives, including root cause analysis and the implementation of corrective and preventive actions (CAPA).
- Data Management and Integrity:
- Ensure the integrity of all QC data by implementing robust data management practices, including proper documentation, storage, and retrieval processes.
- Review and approve QC data generated during pharmaceutical development studies, ensuring that it meets the required standards for accuracy, precision, and reliability.
- Support the implementation and maintenance of electronic systems (e.g., LIMS) used for QC data management.
- Collaboration and Communication:
- Work closely with cross-functional teams to ensure alignment on quality expectations and requirements for pharmaceutical development projects.
- Communicate effectively with internal and external stakeholders, including providing clear and concise feedback on study protocols and reports.
- Represent the QC function in meetings, discussions, and decision-making processes related to pharmaceutical development.
M. Pharmacy or Post Graduation (6years to 9 years experience)
Skills Required
- M. Pharmacy or postgraduate degree
- 6 to 9 years of experience in pharmaceutical QC or related roles
- Extensive experience in quality control within the pharmaceutical industry
- Strong analytical skills
- Deep understanding of regulatory requirements (FDA, EMA, ICH)
- Experience coordinating with CMOs, investigating deviations, and implementing CAPA
- Experience with QC processes, SOPs, internal audits, and continuous improvement
- Experience with electronic QC data systems (e.g., LIMS) and ensuring data integrity
What We Do
DifGen Pharmaceuticals is a US-based global pharmaceutical company specializing in the development and manufacturing of complex, high-barrier-to-entry generic and specialty pharmaceutical products. The company focuses on creating dependable solutions in product development and commercialization to increase accessibility to high-quality medications, thereby leading to the creation of next-generation healthy communities.
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