Currently working as a Pharmacutical consultant Project Manager. Looking for new opportunities.

Essential Duties and Responsibilities:Monitor commercial manufacturing processes and maintain a continuous improvement program, based on metrics, for process optimization, equipment reliability and manufacturing excellence.Project Management: Work closely on client product transfer projects and issues to meet approved quality, timeline and budget requirements.Provide manufacturing floor support for a granulation, compression and coating areas, including equipment installation, equipment upgrades, maintenance issues and process optimization.Write/review/execute and/or approve process and equipment qualifications, validation protocols, batch records and reports.Work closely with a product development group and clients to ensure processes are developed that are robust for commercial application.Provide assistance in QA deviation investigations and CAPA's. Write change control documentation for any process or equipment changes that impact current client products. Obtain approvals for any changes from clients.

Manage the following internal and external (contractor) functions to ensure products manufactured meet company standards for quality, customer service and cost.Essential Duties and Responsibilities:Support contract manufacturing operations in completing and/or approving change controls, deviations and CAPA investigations.Monitor contract manufacturing processes and maintain a continuous improvement program, based on metrics for process optimization.Manage product transfer projects to meet approved quality, timeline and budget requirements.Support our Development Group to ensure processes are developed that are robust for commercial application.Worked closely with the Marketing department to manage product formulation changes for Prenatal vitamins in order to deal with generic competition.Helped develop master plans for packaging changes including RF, RFID and Data matrix and barcode identifications.Represent Operations for Change Control and investigation of customer complaints. Write/review/execute and/or approve process and equipment qualifications, validation protocols, batch records and reports.Provided regulatory with technical summary reports for NDA product submissions to the FDA.

Included providing project leadership, maintenance and technical services support in a Solid Dosage, and Packaging production area at multiple plant sites. Additional responsibilities include the development of technical training and certification programs for Solid Dosage equipment operators.I have written numerous SOP procedures, Safety guidelines and Preventative Maintenance procedures for new equipment as well as updating cleaning procedures for Blending/Granulation/Tableting equipment.

Responsibilities included analysis of capacity utilization of current equipment, the evaluation, recommendation and purchasing of future equipment needs and the installation, validation and training requirements for equipment operations in a Blister Packaging and Solid Dosage manufacturing area. Project Leader Responsibilities have included:Purchase, installation and validation of an Uhlmann Blister Express manufacturing line.Purchase, installation and qualification of an IMA tablet checkweigher and Anritsu capsule checkweigher.Purchase, integration and qualification of new foil strip pouch filler packaging equipment.Purchase, installation and qualification a of Hata HT-HX-51-LDU, Fette 3090 bi-layer tablet press and Fette 2200 tablet press.Perform required engineering studies and process qualification of new blister packaged products to be launched.Process Qualification of Solid dosage products on encapsulation and tabletting equipment.Responsible for evaluation of all new tablet press tooling designs and correcting existing tablet press tooling designs in order to increase tooling life as well as correct product quality issues.Investigated and optimized process operations (Six Sigma) that increased yields on tablet presses and granulation equipment.Project leader on the sale of surplus compression and packaging equipment that bought in over $750,000 in capital savings to the company.Managed between 15 and 25 production operators for 2 years in both a Solid Dosage Compression area and later in a Process production train area that included a granulation, compression, coating and encapsulation area.

Duties included prospective, concurrent, and retrospective validation of manufacturing equipment, development of Installation and Operational Qualification protocols and qualification execution of packaging and processing equipment such as:Development and execution of Installation Qualifications (IQ), Operational Qualifications (OQ) and Performance Qualification (PQ) for production and entire packaging lines.Written Functional Requirement and Functional Specification documents needed to purchase and qualify equipment to meet qualification requirements.Development of system calibration requirements, ensured cGMP compliance for equipment.Additional responsibilities included; the coordination of vendor responsibilities and user requirements in order to facilitate the completion of qualification projects. Qualified a wide range of equipment, including automated tablet presses, a computer controlled (Glatt Fluid Bed) drying process, Label Vision Inspection System (Date & Lot, missing cap), Color Vision Blister Inspection System (cross contamination, partial or missing product) and four complete packaging lines.