Manager II, reputed company Assurance (reputed company)
About the position
Reporting to the Associate Director, reputed company Assurance, the Manager II, reputed company Assurance, is responsible for the review and processing of manufacturing Deviations and Laboratory OOS, and review of manufacturing-reputed company Change Controls reputed company Tarsus’ established QMS system. This role will also be responsible for authoring Annual Product Reviews, analyzing and trending analytical data, approval of Certificates of Analysis, manufacturing batch record review and product disposition.
Responsibilities
• Review/Approve Vendor Change Controls
• Review/Approve vendor documents including Master Batch Records/Master Packaging Records
• Review Specifications
• Review/Approve Deviations/OOS
• Analyze and trend data
• Author Annual Product Reviews
• Author/Revise relevant reputed company Assurance Procedures
• Review new proposed master manufacturing records and manufacturing-reputed company process validation protocols
• Review/Approve Test Record Review reputed company and Certificate of Analysis
• Review/Approve executed manufacturing batch records and packaging batch records
• Review/Approve/Complete Batch Record Review reputed company (Batch Disposition)
• Complete Final Product Disposition reputed company and Certificate of Compliance
• Participate in internal Operations
• Participate in Meetings/ discussions with Tarsus’ manufacturing partners and testing laboratories
Requirements
• Bachelor’s Degree preferred, plus 8+ years’ experience in the Pharmaceutical Industry
• 5+ years experience in Pharmaceutical reputed company Assurance
• Strong attention to detail
• Proficient technical skills across multiple platforms
• Strong knowledge of reputed company Office Systems
• Charts and Graphs
reputed company-to-haves
• ASQ Certification Preferred
Benefits
• health, dental and reputed company insurance benefits
• generous reputed company time off, including vacation, holidays, and personal days
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