Quality Supplier Associate
Monitors Quality Systems for selected PyL 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 PET facilities and their suppliers.
Maintains oversight of PyL PMF sites to assure compliance with regulatory, procedures, standards and contractual compliance.
Performs PyL site qualification audit and provides R&D with required documentation for PyL 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 PyL CMOs, manufacturing sites and suppliers corrective action plan and monitor plan execution following auditing.
Performs audits at API, components and services used in PyL manufacturing process.
Maintain current audit schedule and status in relevant system/tracker
Prepares Annual Product Reviews of CMO??s (PyL)
Collects all documentation for the CMOs used in performing activities relevant to PyL 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 PyL 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.
Working hours: 8:00 AM - 5:00 PM
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 PET Good Manufacturing Practice guidance and FDA regulations regarding the manufacturing of PET 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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