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Quality Manufacturing

Location:
745, United States
Posted:
May 24, 2010

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Pedro Gonz lez Olivero, ASQ CQA, CSSGB

Apartamento 306 A, Miradores del Yunque Rio Grande, PR 00745

Cel. (787) ***-**** abmn3d@r.postjobfree.com

Summary of Qualification

Manufacturing Supervisor with an extensive experience in Pharmaceutical

(Parenterals and Solid Dose products) and Radiopharmaceutical (Radioactive

Parenteral products) Industries. Proficient in Quality Assurance, Quality

Control and Manufacturing areas with a vast experience and hands on

knowledge in managing, planning, organizing, coordinating, and directing

workers engaged in the manufacturing operations and controls. Experience in

managing cost reduction projects. Computer literate with knowledge in

Microsoft Office (Excel, Word, PowerPoint), Outlook, SAP, Production Master

Batch Record, Isotrain, Kronos and Internet. Fully bilingual English and

Spanish.

Core Competency

Supervisor Skills Manufacturing Quality Systems

Process

Quality Audits Quality Control Strategic Planning

Process Project Leadership SME Aseptic

Improvement Complex

Professional Experience

Pfizer (Wyeth), Carolina, Puerto Rico

2007-

Present

Manufacturing and Aseptic Complex Supervisor

. Coordinates, guide, and assist over twenty Manufacturing Operators.

Oversee and manage the Manufacturing activities (Formulation, Filling,

Drying, Sealing and Packaging) associated with the manufacturing of

Parenteral products.

. Perform administrative duties, such as regular (i.e daily or weekly)

employee meetings, Kronos time keeping/attendance/vacation requests,

performance appraisals (input with manager.), disciplinary actions,

job descriptions, interviewing, rewards, recognition, training and

development.

. Provide short-range and long-range planning concerning staffing

requirements, OT requirements, production schedules, process

improvements, and budgets.

. Ensure compliance to standard operating procedures and quality

regulations. Drive department performance through various production

and quality metrics such as output, yield, production schedule and

daily fill rates.

. Perform strategic planning during the Aseptic Process Simulation runs.

. Coordinate the successful simultaneous development of several

projects.

. Conduct training related to Filling, Sealing, Drying and Packaging

operations to the production personnel. Support validation testing and

the launch of new products, components and equipment.

Accomplishments

. Planned, directed, and managed designated projects:

o Reutilization of Tyvek paper in the manufacturing process,

resulting in an annual savings of $250mil.

o Reduction of the utilization of bags used in the Stoppers

Treatment Machines, resulting in an annual savings of $70mil.

. Support in the Power Failure response project in all Aseptic Complex

process.

. Coordinate, planned and managed over 18 Media Fills during 2007-2010,

achieving zero product contamination.

. Improve the OEE in the filling process that exceeded 70%.

. Lead the filling shift with the best OOE percent during two

consecutive years (2008 and 2009).

GlaxoSmithkline (Contract Position by MSSS), Cidra, Puerto Rico

2006-2007

Operational Quality Consultant

. Assist in developing and establishing quality systems programs and

plans that ensure compliance with the Quality System Regulations.

. Analyzed work flow to incorporate quality controls and reduce errors.

Assisted in the development of procedures for consistency in the

quality within the organization.

. Ensure documentation is accurate, complete, approved as applicable,

and adequate to support product disposition criteria.

. Conduct timely review of Production documentation, adhering to

Corporate Quality policies and procedures and applicable regulations.

. Perform activities related to quality indicators to improve the

manufacturing batch record documentation process to assure compliance

with regulations agencies and contract consultants.

. . Assist in the compilation of Batch Record review and final

disposition related documentation.

Accomplishments

. Participate in the new MBR design to ensure compliance with the

Quality System Regulations.

. Develop and participate in self-inspection of procedure, activities

and documentation.

. Reduced documentation errors in the PBR and the Manufacturing Log

Books.

. Active as a SME between Manufacturing and Quality System Department

(Third Party).

CIS-US, 10 DeAngelo Drive, Bedford,

MA

2004-2005

Lead Production Technologist/ MIBG/ Radiopharmaceutical Production

Business Unit

. Coordinates, guide, and assist over eighth Production Technicians.

Coordinates the Production activities (radio chemical synthesis,

filling, final sterilization, Packaging and Shipping), associated with

the manufacturing for radioactive Parenteral products.

. Perform internal audits to ensure that the final product is sterile,

pyrogen-free, radionuclidically and radiochemically pure, safe for

human use and efficacious.

. Responsibilities include insuring quality and regulatory compliance,

review regulatory documents, accurate performance of all procedures,

coordinating workload, staffing, reporting, technical oversight, and

inventory and maintenance of related supplies.

. Provides contamination trends report and statistical analysis to

accomplish internal manufacturing standards. Provide input and support

to engineering and management for modifications and upgrades to the

production equipment/systems.

. Responsible for training, establishing performance objectives,

conducting performance appraisals and coordinating work assignments of

laboratory technologists. Generates decay factor calculation and

Radionuclide Purity Sample for the isotope I-131(MIBG). Perform assays

of radioactive material using Gamma Ionization Chamber and Geiger

counters.

Accomplishments

. Improve the filling process resulting in zero reject batches in a

year.

. Participate in a new stoppers closure system validation project.

WYETH, Carolina, Puerto

Rico

1999-2004

Quality Scientist

. Responsible for the revision of procedures relates to the regulatory

agencies, the Change Control Program, Conformant Standards, GLP, GMPs

and Company Policies.

. Responsible for the development and direction of procedures, methods,

and systems associated with the control and GMP compliance of

manufacturing operations.

. Support manufacturing process development and validation.

. Provided the necessary coaching and mentoring to the Manufacturing and

Quality Departments.

. Provide QA support for batch record review, cGMP record reviews,

complaint investigations review and Change Control related to process.

. Provide training in Quality Process & Techniques to the Manufacturing

and Quality Departments and suppliers.

Accomplishments

. Participate in the Lifecycle of Standard Operating Procedure

Improvement project.

. Obtain the Quality and Excellence Wyeth Global Recognition Honorable

Mention for the implementation of the Lifecycle Standard Operating

Procedure Improvement project.

Education

Metropolitan University of P.R.

Bachelor degree in Natural Science, specialized in Biology-Cum Laude

ASQ- Quality Auditor Academy

ASQ- Quality Engineer Academy

ASQ -Quality Manager/Operational Excellent Academy

Business Excellence Consulting / PRIMEX, Inc.

Lean Six Sigma Green Belt Academy

Trainings / Certification

. ASQ-Certified Quality Auditor: Certification Number- 29120

. ASQ- Certified Lean Six Sigma Green Belt: Certification Number- 1406

. Radiation Safety and Regulatory and Compliance Certification- per

section 120.753, code of MA Regulation 105.

. Train the Trainer

. GMP's for Supervisors

. Isotrain

. CAPA

. Kronos

. SAP

. Leadership Academy

ASSOCIATIONS

. Senior Member of American Society for Quality: Member Number:

63457208



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