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