James Shaver, B.Ch.E, B.S.
Engineering & Operational Management Specialist
James Shaver, B.Ch.E., BS - Engineering & Operational Management Specialist
Qualifications
His forty plus year career with American Cyanamid and American Home Products includes direct manufacturing responsibility for bulk pharmaceutical chemicals, fine chemicals, commodity chemicals and quality assurance responsibilities for drug products, biologics, and bulk pharmaceutical products.
Work History
| 2001 - Present | Senior Consultant | D.H Gold Associates, Inc. |
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Senior consultant with multi-faceted experience in manufacturing and compliance covering APIs, oral and parenteral dosage forms and biologics. Heavy validation experience. |
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| 1991 - 2001 | Vice President, Global Quality Compliance | Wyeth-Ayerst Laboratories |
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Responsible for ensuring domestic and international plant operations were maintained in full compliance with internal and applicable government regulations. Managed Global GMP and DEA Audit and Compliance, Domestic Product Complaint, and the Corporate Validation functions |
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| 1997 - 1999 | Assistant Vice-President, Global Compliance Division | Wyeth-Ayerst Laboratories |
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| Responsible for ensuring domestic and international plant operations were in full compliance with internal and appropriate government regulations. Managed global GMP/Quality auditing functions | |||
| 1995 - 1997 | Assistant Vice-President, Audit and Compliance Division | Wyeth-Ayerst Laboratories |
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Responsible for ensuring domestic plant operations were in full compliance with internal and government regulations. Managed GMP auditing and FDA liaison functions. |
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| 1994 - 1995 | Director, Compliance | Lederle Laboratories |
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Responsible for ensuring all Lederle manufacturing operations were in full compliance with FDA, DEA etc. requirements. Managed GMP Auditing, FDA Liaison and QM Training functions. Managed ongoing technical exchange program with local FDA district personnel. |
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| 1993 - 1994 | Director, Quality Assurance | Lederle Laboratories |
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Responsible for release of Pearl River manufactured oral dosage and bulk pharmaceuticals products. Monitored plant operations for full compliance with GMP requirements. Managed the GMP Auditing function |
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| 1987 - 1992 | Manager Validation Services | Lederle Laboratories |
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Provided direction and management of validation programs for bulk actives, oral and parenteral dosage form products. Managed parenteral dosage validation department at the Carolina, Puerto Rico plant. Developed Lederle validation procedures for computer systems. |
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| 1979 - 1987 | Production Manager | Lederle Laboratories |
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Overall responsibility for bulk Pharmaceutical and elastomer manufacturing operations |
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| 1971 - 1979 | Production Manager | American Cyanamid |
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Managed American Cyanamid’s paper chemical facility in Escanaba,
Michigan acrylonitrile and methyl metharcrylate plants in Fortier, Louisiana |
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| 1968 - 1971 | Technical Sales Representative | American Cyanamid |
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Technical Sales Representative in the mid-Atlantic region American
Cyanamid’s paper Chemicals Department. |
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| 1960 - 1968 | Manager | American Cyanamid |
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| Managed paper chemical manufacturing operations, developed high energy chemicals and worked as shift supervisor and technical assistant to American Cyanamid’s facilities in Cloquet, Minnesota, Kalamazoo, Michigan, New Castle, Pennsylvania and Bound Brook. | |||
Education
| 1960 | B.Ch.E University of Cincinnati |
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