Quality Supplier Associate
Quality Supplier Associate
OverviewMonitors Quality Systems for selected CMO PMFs. Performs audits and qualification status assessments. Provide technical expertise to ensure manufacturing facilities, processes and support systems are in compliance with NDA and CGMP regulations for Diagnostic Imaging Agent facilities and their suppliers.
- Maintains oversight of PMF sites to assure compliance with regulatory, procedures, standards and contractual compliance.
- Performs site qualification audit and provides R&D with required documentation for comparability protocol preparation
- Support all Quality Systems for the assigned PMF Reviews deviations, CAPAs, change controls, OOS and complaints and provides feedbacks to CMOs and upload them into QMS system
- Monitors metrics relating to Quality Systems and manufacturing processes covering deviations, CAPAs, change controls, OOSs and complaints.
- Approve CMOs, manufacturing sites and suppliers corrective action plan and monitor plan execution following auditing.
- Performs audits at API, components and services used in manufacturing process.
- Maintain current audit schedule and status in relevant system/tracker
- Prepares Annual Product Reviews of CMO’s
- Collects all documentation for the CMOs used in performing activities relevant to manufacturing and testing such as Master Batch Records, EM reports and others as applicable
- Provides feed backs for the review of Master Batch Records and critical SOPs from the CMOs.
- Reviews EM reports, Media Fills BR and BR based on procedures in place
- Provides technical support for FAR and recall evaluation/contents
- May conduct internal quality and external clinical supplier audits
- Participates into weekly/monthly/quarterly meetings for supply with CMOs
- Support inspection readiness, participate in regulatory agency inspections and provide audit support, as required.
- Build a strong working relationship with R&D, Supply, and Development and contribute to a high performance culture.
- Collaborate well with project team and work efficiently in a team environment. Communicate effectively with management, contractors, consultants and vendors.
- Support continuous improvement activities for the managed activities, as needed.
- Actively demonstrate the company values of accountability, quality, efficiency, customer service, collaboration and safety.
Experience and Education Requirements
- Minimum Education: Bachelor degree in a life science, technical or other related field
- A minimum of 5 years of practical auditing experience in the pharmaceutical or medical device industries
- Must demonstrate thorough knowledge of conducting effective investigations. ASQ Certified Auditor a plus.
- Demonstrated knowledge of CGMPs practices required.
- Working knowledge with Diagnostic Imaging Agent Good Manufacturing Practice guidance and FDA regulations regarding the manufacturing of drugs is preferred
- Experience with pharmaceutical quality systems and quality assurance concepts.
- Excellent Documentation skills
- Excellent technical writing skills.
- Knowledge and understanding of GCPs and GMPs
- Ability to work effectively with cross-disciplinary teams and with Suppliers.
- Flexibility and Adaptability
- Experience in Sterile Manufacturing and CMO Management preferred
- Strong problem-solving skills, excellent communication skills both written and verbal.
- Proficiency with Microsoft Office to include PowerPoint, Adobe Acrobat, and SharePoint.
- Demonstrated ability to work independently and in cross-functional teams.
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