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Packaging
Manager, 04365
Industry:
Packaging
Resides:
Pennsylvania
Salary:
$Open
Relocate:
Yes
On
the Market:
RECRUIT
SUMMARY
cGMP trained. Directed a cGMP/Safety training program. Managed the packaging
of the following; sterile products, class III and IV liquid and solid
dosage pharmaceuticals. Managed/Coordinated the validation/qualification
of the packaging dept. and its supporting utilities.packaged/manufactured
the following; lotions, creams, oils, powders, and
aerosols. Strong written and verbal communication skills. Developed company
and departmental SOP's. Proficient in the productive management of time
and resources. Developed departmental budgets and business plans.
Managed/Coordinated the design of components and the requisition of equipment.
WORK HISTORY
2001- Present Manager, Schering-Plough
Responsibilities: Responsible for the validation/qualification of new
and legacy equipment and Utilities within the pkg. dept.. Liaison between
Schering-Plough and outside validation consultants. Review, edit, and
approve all protocols.
Ensure cGMP and Schering compliance requirements are met. Scheduling.
Adhere to validation timeline. Negotiate validation work-order requests.
Member of 5-person team which negotiated multi-million dollar validation
project.
1999-2001 Manager ILP Department, Ben Venue Labs, Bedford, Ohio
Responsible for a three shift operation consisting of 4 supervisors, 16
line technicians, and 120 inspectors. Capital budget of $2mm. Liquid and
Lyophilized sterile/non-sterile injectable products. Increased units/month
produced by 1.25mm by better utilization of labor, time, and equipment.
Responsible for hiring and training of departmental employees.
1995-1999 Packaging Manager/Dir. Corporate training, Mikart Inc., Atlanta,
GA
Developed and implemented departmental SOP's. Developed and improved training
procedures which improved quality and decreased discrepancies. Managed
7 supervisors, 49 line workers, and 3 mechanics. Qualify and validate
equipment and procedures.
Responsible for sizing components, planning and scheduling, hiring, evaluating
and disciplinary actions of personnel. Purchasing and controlling inventory
of direct and indirect supplies. Implemented cost improvement projects
that increased line efficiencies by 50%. Engineered packaging lines. Responsible
for sourcing and purchasing
of equipment, change parts, and supplies. Helped develop a preventative
maintenance program. Redefined departmental jobs to streamline workforce.
Departmental budgets and variances. Developed corporate cGMP/SAFETY training
program in response to FDA inspection.
1994-1995 Assistant Director of Packaging Operations, Inwood Labs,New
York
City, NY
IQ/OQ and cleaning qualifications of packaging equipment in new facility.
Direct operation of packaging department. Budgets. Departmental personnel
decisions.
Scheduling.
Develop SOP's. Training.
1986-1994 Packaging Supervisor, Carter-Wallace Inc., Cranbury, NJ
Supervised the packaging of the following; liquids, solids, creams, lotions,
oils, powders, tablets/capsules, sterile products, and aerosols. Supervised
the return merchandise department. Manufactured liquids, tablets, and
capsules. Training. supervised up to 100 employees.
EDUCATION/MEMBERSHIPS
B.S. International Business/Marketing, Quinnipiac College, Hamden CT.
Member; IOPP,PDA, and ISPE.
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herein. 100702
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