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Manufacturing Manager

Location:
7885
Posted:
March 09, 2010

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Resume:

COLIN P. DONEGAN

** ****** **** *******, ** ***85

Home Phone: 973-***-**** Cell Phone: 973-***-**** Email: ********@*********.***

OBJECTIVE

To acquire a supervisory or managerial level position in a company that could best use my

experience and expertise in Pharmaceutical industry or similar manufacturing environment.

PROFESSIONAL EXPERIENCE

ABBOTT LABS (FORMERLY KOS) May 2006-December 2008

Shift Manager, Production

Supervision of Granulation, Compression, and Coating departments manufacturing

process insuring cGMP, Standard Operating Procedures and company policies

compliance.

Authoring and follow up of deviations in Trackwise computer system.

Timely review of Compression and Coating batch records to expedite batch release.

Production scheduling and execution

Recognition for work performance by achievement of 3 (Three) Abbott Silver awards

ABBOTT LABORATORIES 2004-2006

Manufacturing Supervisor

Direct Supervision of Central Weighing and Granulation sections of the Solid Dosage

Department of Manufacturing and Chemical (API Manufacturing) Department to insure

all government agency regulations and company policies are followed.

No FDA observations during audit in 2005.

Responsible for access to the narcotics vault in handling and reconciliation of CIII and

CII narcotics.

Increase batch production in Chemical Department from 58 in 2004 to 73 batches in 2005

with less overtime.

NOVARTIS PHARMACEUTICALS (Formerly Sandoz Pharmaceuticals) 2002 - 2003

Manufacturing Project Coordinator

Assisted Manufacturing Engineers on cleaning and equipment validation projects

Cleaning Validation representative for Manufacturing, attending monthly meeting and

responsible for monitoring and timelines for Cleaning Validation activities in

Manufacturing.

Responsible for documentation of Change Control documents and updating of SOP’s

effected by changes.

Manufacturing Supervisor (1997-2002)

Supervision of Pharmacy (Dispensing) Department in a team environment for all (3)

three shifts.

Responsible for cGMP/SOP and company policy compliance.

SOP writing and revisions

Review of completed batch records and new batch record revisions.

Responsible for warehousing and segregation of materials and insuring only QC/QA

released raw materials are used using FIFO method.

Responsible for AWDS (Automated Weigh and Dispense System) at administrative level

in Bill of Materials maintenance and troubleshooting problems.

SANDOZ PHARMACEUTICALS (1987 – 1997)

Foreperson

Direct supervision of the manufacturing processes on the production floor in the Central

Weighing and Granulation Departments of Manufacturing.

Performed all administrative duties in BPCS inventory system in issuing raw materials

and reviewing completed batch records.

Assumed position of acting manager to Associate Director of Solids Department during

his absence due to company merger. I was responsible for all departments (Central

Weighing, Granulation, Compression, Encapsulation and Coating) in Solids Department.

Sandoz Technical Operations 1987 Excellence Award.

Utility/Pharmaceutical Operator (1983-1987)

Experienced in wet granulation, dry blending, fluid bed and oven drying, and particle

sizing using PK blender, Collette gral, Stokes tornado mill, Russell sieve, Frewitt

oscillator and other production equipment.

Conformance to GMP and SOP requirements by following batch records accurately in

Central Weighing and Granulation processing.

Rotated into Central Weighing functions of verifying released status of raw material,

dispensing and accurate weighing to batch record specifications.

Material Handler (1979-1983)

Supplied Packaging Department production lines with semi-finished tablets/capsules and

packaging materials needed and adhered to GMP and SOP compliance.

Mailroom Clerk (1979)

Responsible for sorting and distributing departmental and external mail.

EDUCATION

High School Diploma, Morris Knolls High School, Denville, New Jersey 1976

Supervisory Management Development Course, Rutgers University Center for

Management Development 1987



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