Daniel Bitler Email & Phone Number

SCHERING-PLOUGH, Kenilworth, NJ – 1/09 to 3/09 QA Manager, Pharmaceutical Sciences Quality (contract position)(Contract cancelled due to Merck/SP merger) • Receipt, documentation and review of Complaints related to Global Clinical Supplies. All information entered and trended in the TrackWise software program. Direct interaction with CROs/clinical sites to evaluate and close the complaints. Began managing the Complaints area at the beginning of February, and there was a 24% decrease in the number of open complaints the very first month. • Review and monitoring of Investigations related to Global Clinical Supplies. Provide technical support at Investigational Review Board meetings. Direct interaction with Clinical Supplies Manufacturing, Packaging, and Laboratories, as well as CROs.• Gap analysis of 2007/2008 Complaint files. 100% of 2007 files located, compiled and archived. 95% of 2008 files located, compiled and filed; January and February 2008 files archived. Gap analysis of level 2 and level 3 SOPs.• Special projects.

• Responsibilities revolved around all aspects of the QA function for the manufacturing / packaging locations comprising Actavis Totowa LLC and included the review and resolution of compliance issues related to product quality, QA, cGMP, etc.• Initiated the formal CAPA program and managed the transfer of the Product Complaint program from RA to QA.• Managed the sampling and evaluation of all incoming raw materials, printed materials, and packaging components.• Directed the review and approval of all manufacturing/packaging batch records and the associated product releases.• Reviewed and final approved change controls, qualification/validation reports, SOPs, product complaints, investigation/deviations, APRs, etc.• Represented Actavis as liaison for all third-party customers, including the coordination and management of all third-party customer audits.• Directly managed a QA Manager, two QA Supervisors, and a one shift operation of 10 additional QA employees.

• Responsibilities revolved around all aspects of the QA function and included the review and resolution of compliance issues related to product quality, QA, cGMP, etc.• Evaluated and coordinated the implementation of the TrackWise computer software program for the management of investigations and CAPA.• Chaired the Management Review Board, Investigations Review Board, and Change Control Review Board meetings.• Managed the sampling and evaluation of incoming raw materials, printed materials and components, the review of manufacturing/packaging batch records and the associated product releases.• Reviewed and final approved change controls, qualification/validation reports, SOPs, and investigation/deviations/CAPA documents, and all APRs.• Reviewed and assisted in the resolution of compliance issues related to product quality, QA, cGMP, etc.• Directly managed five Managers, and a three shift operation of approximately 60 additional QA employees.

• Responsibilities revolved around all aspects of the QA function for the one North American Sanofi-Synthelabo packaging site; the twenty contract manufacturers in the US, Canada, and Puerto Rico; the 10 co-marketers; and all associated suppliers. • Addressed all compliance issues related to QA, cGMP, 21 CFR Part 11, change control, and documentation systems associated with the manufacture of Sanofi-Synthelabo products. • Conducted PAI (pre-approval inspection) and mock inspections of several Sanofi-Synthelabo manufacturing sites in Europe for products distributed to the United States. • Managed the vendor/supplier auditing program and directly supervised the Manager of Vendor Auditing. • Represented the QA department for three due diligence projects related to product acquisition and co-marketing agreements. Served as the QA representative for product launch teams.

• Responsible for the auditing of over 300 vendors, suppliers, and contract manufacturing/packaging companies for compliance with cGMPs, specifications, SOPs, and filings. These audits were conducted for all divisions of Warner-Lambert worldwide. • Collaborated in the development of a program for training and qualifying site auditors at every Warner-Lambert facility worldwide.

• Provided cGMP / compliance / QA training support for the Pharmaceutical Sector manufacturing locations; the research & development group in Ann Arbor, Michigan; and the Pharmaceutical QA group in Morris Plains, New Jersey. This included the design, development, and presentation of both sector-wide and site-specific training programs. • Collaborated in the development and implementation of a cGMP Orientation Guide for the Warner-Lambert organization.

• As the initial individual in this position, designed and implemented training standards and programs, including developing equipment training manuals, job classification training guides, annual SOP review programs, and skills evaluation programs for assessing refresher training needs. • Evaluated and installed a computer interactive program for the training of GMP’s for the aseptic filling area.

• Responsible for the overall operation and cGMP compliance of the afternoon shift Sterile Filling area. Directly supervised a syringe-filling line, a liquid vial-filling line, and an ointment tube-filling line. The vial-filling line also included the operation and monitoring of lyophilizers. • Responsible for training employees on performing Statistical Process Control testing during the filling process and for monitoring product quality, environmental conditions, labor utilization, line efficiencies, and any personnel issues on a daily basis. • Directly managed two Supervisors, an Associate Section Head, and over 40 employees.

• Responsible for supervising filling operations and cGMPs on the Large Volume Parenteral (LVP) glass line, the plastic blow/fill/seal (BFS) lines and the solution preparation area. • Was team chairman of a task force that produced annual savings of $300,000 through the more efficient use of personnel and equipment.

• Supervised the production and packaging of products from 3,000,000 pounds of potatoes and 500,000 pounds of corn weekly. • Start-up supervisor during Frito-Lay Corporation’s first Ishida Statistical Weigher and Woodman Universal Bagmaker installation project. • Responsible for in-process product and packaged product quality, production scheduling, labor utilization, and resolution of customer complaints. • Directly supervised over 50 employees.