Experienced Validation Manager/excellent GMp & management skills |
Post jobs
|
Resume Text:
|
JOSE TIRADO
HC-* Box *****
Arecibo, P.R. *****
Tel. 787-***-****(best time to call: 3:00 p.m. to 5:30 p.m., E.T.)
j.tirado50@
yahoo.com
Synopsis
Holds a BS in Chemical Engineering from the University of Puerto Rico and is a veteran in FDA regulatory compliance affairs. Was Validation Manager for several world class pharmaceutical companies such as Upjohn Manufacturing Co., Sterling Pharmaceuticals and Nycomed Imaging, Inc.
Experienced in the validation of aseptic processing, solid and liquid dosage formulation facilities. Has developed Quality Assurance programs and has thorough knowledge on GMP auditing. Has conducted several pharmaceutical plants start-up and commissioning.
Was consultant in the areas of validation and FDA regulatory compliance for pharmaceuticals in England, Norway, Mexico, Colombia and Puerto Rico while leading the consulting business development toward marketing excellence. Audited and converted pharmaceutical manufacturing processes into full GMP compliance and has assisted companies to defend their position in front of the FDA inspectors.
Work Experience
VALIDATION MANAGER September 1993 to Present
PRO QUALITY CORPORATION
Core Responsibilities
-develop and administrate validation budgets
-approve validation projects spending
-secure capital funding as required
-manage cost and income for the validation projects
-supervise validation staff
-perform training on FDA regulatory issues
-review the validation and FDA regulatory work
-provide leadership and direction to achieve organizational objectives
-perform projects scheduling
-perform presentations to client body
-provide technical advice to validation and compliance professionals
-generate and execute Validation Master Plans
-perform validation activities in all disciplines of validation (Process, Equipment, Laboratory, Computers, Cleaning, or Facilities)
-perform validation assessments
-draft, review, and approve validation strategies and validation implementation plans
-investigate and prepare Exceptional Condition Reports
-develop, review, approve, and execute validation protocols
-analyze validation data, prepare, and review final validation reports
-file and scan executed validation protocols in the validation archive system
-support FDA and customer audits as required (with participation, retrieving data and documentation)
-lead and or participate in external and internal GMP audits
-provide audit responses for audit observations
-review and assess Validation Change Controls
-enter data into validation logs
-author, review, and approve (when required) Validation department SOPs
-provides backup for Documentation Administrator and QA / Validation Engineers
-perform FAT testing, plants commissioning and start-up
-develop Quality Assurance programs
-assist in Corrective and Preventive Action (CAPA) and Deviation programs
-generate and/or review Batch Records for solid dosage and aseptic areas to assure FDA compliance
-develop and/or review Annual Product Review (APR) documentation for solid dosage and aseptic areas
-audit documentation pertaining to complaints investigation
-develop SOP’s and perform training to Production personnel
-review P&ID drawings to comply with FDA regulations
VALIDATION MANAGER February 1987 to August 1993
STERLING PHARMACEUTICALS, INC.
administrate the validation budget and provide projects scheduling
approve validation projects spending
secure capital funding
manage cost and income for the validation projects
supervise the validation department and serve as liaison between QA, Engineering and Production
provide training to Production personnel on GMP concepts and SOP’s
review and approve the validation work
provide technical advice to the validation staff
conduct risk assessments related to incident reports (deviations) to generate Corrective and Preventive Actions (CAPA) to eliminate threats
Generate clean utilities monographs
Perform design review and validation for new products introduction and Plants start-up
assure production areas modifications were properly validated following plant’s Change Control procedure
conduct internal and external GMP audits
assist QA Director during plant’s FDA inspections
design and execute process and cleaning validation protocols for solid and aseptic areas
assure compliance with safety standards, FDA and internal policies
Operating and Cleaning SOP’s generation for production machinery
in charge of API and aseptic plants start-up and validation
prepare and execute Validation Master Plans for solid dosage forms facilities and aseptic areas
design, and execute validation protocols (IQ,IOQ,OQ,PQ,CSV)
prepare validation technical reports
member of an international GMP audit team for pharmaceutical plants throughout U.S. territory
perform FAT testing and commissioning
review process layouts (P&ID’s) and general drawings during the construction process
validate HVAC system for solid dosage and aseptic areas
equipment/systems validated
-HVAC for class 100/1000/10,000/100,000 and compressing rooms.
-WFI
-Clean nitrogen/compressed air
-Cooling tower water
-Chilled water
-Clean steam
-House steam
-DI water
-Compounding tanks
-Filling machinery (class 100) for vials, bottles and ampoules
-Ampoules inspection systems
-Packaging equipment
-Autoclaves
-Vials/bottles washers
-Glass tanks
-Solid dosage equipment/facilities
-Packaging equipment
-Computer validation
-Cleaning validation
-Process validation
Project Engineering
o in charge of facilities layout modification, FAT testing, construction, commissioning, equipment installation and validation to comply with class 100,000
o verification of filling equipment construction(FAT), equipment installation and validation for class 100
o execute capital projects exceeding $30 millions
o supervision of outside contractors and bidding procedures
Education
BS in Chemical Engineering (1982)
University of Puerto Rico
Special Skills And/Or Knowledge
- knowledge on Quality systems and systems auditing
- Possess good project management skills
-self motivated and problem solving
- the ability to work collaboratively with others toward mutual objectives
- excellent listening and questioning skills
- good math and technical writing skills
- proficient in the operation of computers(MS word, power point, excel)
- the ability to identify root cause, develop creative solutions to problems and continuously improve systems and processes
- leadership: Including recognizing strengths and weaknesses in others as well as myself
- knowledge of FDA (GMP) and ICH regulations
- excellent validation knowledge
- bilingual in English and Spanish
- knowledge on KAYE Digistrip validator and SPC methodology
|
|
Similar ResumesQA QC Engineer
Canada, AB
- cswip3, ndt, qc engineer, wps, welding inspector,...Project Manager Business Analyst Sales Management
Los Angeles, CA
- caregivers, ebusiness, seo, esri, jde, barbara,...Engineer Project Manager Quality Electrical Engineering
El Paso, TX
- qip, product launch, combo, 13485,...Regulatory Validation Manager, Global Services
Bergenfield, NJ
- pks, plateau, edms, kofax, project control, mirror,...Project Manager Management Business Marketing
Irvine, CA
- maximo, cognos, scrum, dms, sharepoint, npi, agile,...Manager Project Administrative Assistant Quality Control
Birmingham, AL
- control analyst, body shop, analytical chemistry,...Engineer Design Mechanical Engineering Project
Thousand Oaks, CA
- stress analysis, injection mold, der, gearbox,...Project manager
Wilmington, DE
- enviromental, chemist, pharma, jewelry, merck,...GMP Manager
Temecula, CA
- roland, plant operator, capa, dcs, polymer,...Validation
Schaumburg, IL
- urology, specific, aers, testing tools, items,... |
