8+ years of relevant experience in a GMP environment . Detail-oriented Supervisor with strong organizational skills, planning skills
and strong understanding of the current pharmaceutical industry and applicable regulations in both QC and QA.
|SKILLS: Organizational skill, conflict resolution, troubleshooting, change management and project management STRENGTHS: Provider and Influencer (Based on the "Stand Out Assessment Results for Strength Roles)|
Reviews master batch records, labels, specifications and other pre-production documents for commercial solid dose drug products in compliance with FDA and international health agency requirements. Reviews routine manufacturing and quality control data for in-process and finished products. Performs final disposition for finished products (reject/release). Provides disposition for quality issues identified to manufacturing and packaging record documentation issues. Conducts reviews of development batches. Performs reviews/release of raw materials and packaging components. Involved in special assignments and higher level quality activities as needed. Good background on Change Control Requests. Develops training material and trains manufacturing and packaging personnel on Batch Record documentation. Interacts with other departments to resolve documentation issues. Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs). Performs other duties as assigned including the handling of Finished Goods retains manufactured by Sandoz for distribution and annual inspection. Adheres to all applicable procedures, cGMPs, company policies and any other quality or regulatory requirements.May conduct investigations and corrective and preventive action (CAPA) recommendations related to manufactured products.
Writes and/or implements changes to controlled documents (e.g., SOPs, specifications, methods, etc.) as needed.
Managed the QC sample control and administration group and the Laboratory and Information Management Systems (LIMS) group. Reviews and approve SOPs related to the department. Assist in compliance audits as required and participates and helps provide answers during FDA and internal Novartis audit, handles investigations/deviations associated with sample administration and LIMS related issues, supports the Standard Coordinator with Standards inventory management/proper storage, manages glassware availability for the whole laboratory ; handles the issuance of validation document number and oversees management of QC documents prior to permanent archival, had worked with the QC Scheduler to track and trend laboratory performance and operations through lab metrics, and oversees compliance with QC Controlled Substances documentation and accountability procedures.
Provides support and oversees the VWR Inventory Management Sandoz Wilson site Achievement: Galaxy Awardee for Going "Above and Beyond" (April 22. 2009)
Handled instrumental (HPLC and GC) and wet analysis of raw materials; investigations and deviation associated with raw material testing .
Facilitated the Residual Solvent Project (6/25/2008-12/15/2008), by coordinating with various departments to pull information and all requirements necessary to comply with USP <467> General Chapters.
As a Lead of the Control Center Project (5/09/2009 – Sept. 30, 2009), had worked with a consultant and various Sandoz department heads to set up the Sample Control Center . Project included the creation of all RM and FP worksheets used for testing, organization of sample flow processes in Quality Control, development of metrics and trending to track laboratory activities, training and development of staff to implement kitting that defines which lots and tests can be campaigned together for QC testing and use LIMS from sample receipt process to release.467>
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