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Quality Assurance Manager / Sr. Quality Assurance Specialist at Ocugen
About Ocugen
Ocugen is a leading biopharmaceutical company focused on developing novel treatments for various diseases. With a strong commitment to quality and compliance, we strive to make a positive impact on patients’ lives. Our India office in Hyderabad plays a crucial role in our global operations.
Job Location: India Office – Hyderabad
Description
The Quality Assurance Manager / Sr. Quality Assurance Specialist is responsible for fostering a culture of quality, efficiency, and excellence ensuring that quality and compliance are integrated into the day-to-day operations and long-term Quality strategy. This role works closely with Head of Regulatory Affairs & Quality Assurance to support quality activities for Ocugen’s vaccine, cell and gene therapy product portfolio. This role focuses on the validation and qualification of equipment, systems, and manufacturing processes, along with providing oversight to project teams. The Quality Assurance Manager / Sr. Quality Assurance Specialist will collaborate cross-functionally to identify and remediate compliance gaps and contribute to the continuous improvement of our quality systems.
Job title is commensurate with experience and skills.
Duties and Responsibilities
QA lead for Ocugen’s cross functional team
- Review and approve master batch records and executed batch records, batch release and disposition for clinical use
Quality System Records
- Engage in review and approval of Quality System records, including deviations, CAPAs, change controls, participate or facilitate FMEA/Root cause analysis as appropriate and assess product quality impact
Deviations, CAPAs & Investigations
- Ensure Deviations, CAPAs & investigations are closed out within the required timeframe
GMP Raw Materials
- Inspect and release GMP raw materials for onsite GMP facility and review & approve external GMP raw materials for quality and compliance to US FDA and EMA regulatory standards
QA Support and Oversight
- Provide hands-on QA support and oversight to internal staff, suppliers / contractors to ensure adherence to SOPs and relevant Good Regulated Practice (GxP) requirements
System Lifecycle Documentation
- Review and grant final approval to system lifecycle documentation, including URS, Validation Plans, Qualification Protocols, Qualification Summary Reports, and Requirements Traceability Matrices
Remediation and Changes
- Participate in the remediation of deviations, identifying compliance gaps, and advising on changes to existing systems
- Attend project meetings, offering valuable feedback and guidance on any QA-related issues
Analytical Methods and Reports
- Review and approve analytical methods, method qualification / validation protocols and reports, stability protocols and reports, shelf-life extensions, generation of certificates of analysis as needed, shipment of product to the clinical sites for subject dosing and reconciliation of unused vials
Audits
- Participate in internal and external periodic audits, vendor / supplier audits, planning, execution and reports
QA Dashboards and Metrics
- Maintain QA dashboards to track and monitor all quality milestones, work with consultants for quality events trending and metrics, and assist the quarterly management review of quality trend reports
Qualifications
- Master’s Degree & 4 years of experience or Bachelor’s degree preferably in Chemistry, Microbiology, or related sciences with 5 years of experience in cGMPs related to Biologics, Vaccine, and/or Cell and Gene therapy products
- Strong knowledge of ICH guidelines, cGMPs, US FDA regulations and guidelines for manufacturing and testing of Biologics / Vaccines / Cell & Gene therapies for clinical studies
- Experience leading Deviations, CAPA reviews, and investigations
- Experience with compiling and presenting departmental Key Performance Indicator metrics to leadership
- Fluent in English, excellent oral and written communication skills
- Strong attention to detail, meticulous while reviewing critical documents, and ability to lead others in a team setting
- Experience working with consultants and CDMOs
Keywords: Quality Assurance Manager, Sr. Quality Assurance Specialist, Ocugen, Vaccine, Cell and Gene Therapy, Quality Systems, Compliance, cGMP, Biologics, ICH guidelines, US FDA regulations, Quality Metrics
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