Manager Quality
Resume:
Ricardo J. Gonz lez Santiago
Chalets de Bairoa, *8 Ruise or Azul, Caguas, Puerto Rico 00727-1213
*********.*******@*****.***
Summary of Qualifications
Dynamic Quality Operations professional with extensive experience in the
Pharmaceutical Industry. Managerial exposure in areas such as: Quality
Control Laboratory, new technology transfer, analytical methods and product
process validations, incoming inspection of raw materials, and finished
goods disposition. Knowledge of modern computerized laboratory equipments.
Hands on experience in internal and external audits. Fully compliant with
FDA, cGMP, and OSHA Regulations. Analytical thinker with proven
investigative capabilities. Strong leadership skills with the ability to
influence and motivate people. Capable of performing multiple tasks in a
high pressure environment. Quality, safety and team work oriented.
Computer literate with knowledge of SAP-CAPA, TrackWise, LWLIMS, Empower
and Microsoft Office. Fully bilingual in English and Spanish. American
Society for Quality Certified Quality Auditor.
Accomplishments
. Evaluated and collaborated as QC lab representative in Site's TOC
(Total Organic Carbon) on line implementation representing a
significant cost saving project and a laboratory investigations
reduction.
. Managed laboratory group for product launch in accurate timely
completion. This was a Company strategy to minimize market share
impact with generic brand product.
. Managed laboratory team in Analytical Method Transfer activities
completion from US Site to PR Site. Based on Business decision of
closing out a US Site, all the Consumer production was transferred to
PR on a timely schedule.
. Collaborated with Site FDA Audit Response team to answer issued
warning letter and make quality systems improvements. The Site was
audited with Zero observations afterwards.
. Participated and managed laboratory group in LEAN labs and 5's
principles implementation within the QC Finish Product laboratory
improving significantly laboratory efficiency and reducing cycle time
metrics.
Professional Experience
Pfizer Consumer Healthcare (previously Wyeth Consumer Healthcare), Guayama,
Puerto Rico
QC Laboratory Leader- Product Validation Support
2009 - 2009
. Managed seven Analysts. Work hand in hand with Technical Services
with laboratory chemical testing for process validation samples, and
cleaning validation/certification activities on a timely manner to
assure projects schedule attainments.
. Revised analytical data and provided final disposition. Provided
support to marketed finished products and Incoming Raw materials
areas.
. Back up the QC Laboratory Director in decision making during
Laboratory Investigation process, disciplinary actions, laboratory
procedures revisions, approvals and task prioritization assignments.
. Reviewed and approved Method Transfer, Method Validation and Technical
Services New Product Process Validation and Process changes validation
protocols as QC Representative.
Wyeth Pharmaceuticals Company, Guayama, Puerto Rico
QC Laboratory Manager 2005 -
2009
. Managed up to three supervisors, twenty five Analytical Chemists and
QA Technicians. Cost savings oriented.
. Responsible for testing and approval of all incoming raw materials,
packaging components, and finished products. Sampling, testing and
final disposition of the purified water system. Final revision of
analytical data related to raw materials, packaging components, and
finished products when required.
. Prepared, followed-up, and approved laboratory investigations using
Trackwise/SAP-CAPA Systems. Prepared, followed-up, and approved
SOP's, Materials Testing Standards and Testing Methods using GX Pharma
System.
. Participated in manufacturing daily schedule meetings to assure the
best service to production area. US and International Data Pack
evaluation for Regulatory submission.
. Prepared required change controls related to raw material, packaging
components, and finished product areas. Reviewed and approved
Qualification/validation documentation for new laboratory equipments.
. Conducted meetings with employees and walk-through audits within the
laboratories to assure compliance with established regulations and
procedures. Assisted FDA, International Agencies, Global Corporate
and External/Internal Auditors during the cGMP inspections.
Wyeth Consumer Healthcare, Guayama, Puerto Rico
QC Laboratory Supervisor- Dietary Supplements/
QC Laboratory Senior Supervisor- Technology Transfer
2001 - 2005
. Supervised up to ten Analysts. Performed supervisory daily duties
such as: coordinated chemical testing of marketed finish product and
of process validation samples and method transfer activities on timely
manner to assure schedule attainments. Wrote, conducted and completed
laboratory investigations.
. Revised and provided final disposition to analytical data.
. Supervised all method transfer activities within the QC Laboratory.
Prepared and reviewed Method Transfer and Method Validation Protocols.
. Acted as QC Laboratory Manager during Manager absence or when
required.
. Work hand in hand with Technical Services in New and current process
validation projects and Cleaning Validation testing.
. Quality Systems exposure; change control committee member, regulatory
data submission, regulatory/internal commitments tracking and closure.
Wyeth Consumer Healthcare, Guayama, Puerto Rico
Analytical Chemist II / Analytical Chemist III / Senior Chemist
1993 - 2001
. Performed chemical analysis to raw materials and finished products.
. Performed some supervisory duties such as raw data validation,
approval and final disposition of raw materials, participated on
plant's scheduling meetings, member of continuous improvement teams,
and interfaced with external laboratory equipment suppliers.
. Participated in new product and method transfer validations.
. Strong exposure to HPLC, ICP, Gas Chromatography, Dissolution Bath,
Infrared and Near Infrared Spectroscopy, TOC analyzer, Water
Content/Moisture Analyzer and Malvern Particle Size Analyzer.
Merck Sharp & Dohme Qu mica, Arecibo, Puerto Rico
Q.C. Chemist
1993 - 1993
. As part of the start-up staff of this pharmaceutical facility,
performed chemical analysis of incoming raw materials and in-process
finished products to confirm its identity and composition.
. Developed and wrote SOP's, instrument operation qualifications, and
methods validation.
. Performed supervisory duties such as verifying analytical data;
conducted safety talks meetings, served as moderator in Q.C. staff
meetings and established contact with external laboratory equipment
suppliers.
Education
Universidad del Turabo, Gurabo, Puerto Rico
MBA in Materials Control Management
Pontificia Universidad Cat lica, Ponce, Puerto Rico
BS Degree in Chemistry / License Chemist
Pontificia Universidad Cat lica de Puerto Rico Medical Technology School
Medical Technology Certificate - Dean's List
Trainings / Certifications
. American Society for Quality Certified Quality Auditor.
. Leadership Academy Workshop/ Risk Management Assessment for Managers
. Laboratory Investigations - Writing Effective Investigation Reports/
Root Cause Problem Solving
. LEAN Manufacturing/ Value Stream Mapping
. Trend Analysis in the Biopharmaceutical Industry
. Civil Treatment for Managers
. Data Reviewer Certification
. CPR and First Aid
. Laboratory Instrumentation Troubleshooting - HPLC/GC, TOC Analyzer, UV
. Current Good Manufacturing Procedures for Supervisors (cGMP's, cLOP's)
. OSHA and NIOSH Regulations/ Waste Management and Disposal
. Hazardous Materials Communication Program
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