Raimundo Ilarraza
BSc in Chemistry from Interamerican University, MSc in Environmental Analysis from Universidad del Turabo, Validation Specialist at AstraZeneca/iPR Pharmaceuticals, Inc since 09, Validation Specialist at Wyeth Pharmaceuticals ( 2009).
| Headline: | Startup Member |
| Work status: | Employed Full-Time |
| Industries: | Biotech, Food and Drink |
| Skills: | Engineering, English, Languages, Leadership, Software Engineering, Spanish, System Administration, Unix |
| Groups: | Enterprize 2008 [INACTIVE], Enterprize 2009 [INACTIVE], [INACTIVE] EnterPRize 2010 |
| Interested in: | Brainstorming, Consulting opportunities, Employment opportunities, Finding business partners, Finding cofounders, Finding team mates, Meeting new people, Offering Expertise, Professional opportunities, Promoting my startups, Recruiting for my startup, Starting a company |
| Schools: | Universidad del Turabo, Universidad Interamericana de Puerto Rico |
WORK EXPERIENCE
| Employer: | AstraZeneca/iPR Pharmaceuticals, Inc |
| Position: | Validation Specialist |
| Time period: | November 2009 - Present |
| Description: | Authored and executed IQ/OQ and validation report for Mettler Toledo Analytical Balance System XS-204 • Authored Risk Assessment for the Metal detector system for the encapsulation area • Authored and executed IQ/OQ and validation report for the metal detector system •Perform qualifications/validations for product/processes and equipment, as required •Organized meetings with clients to meet their satisfaction. |
| Employer: | Pikaera |
| Position: | Self Employed - Catering Services (Owner) |
| Time period: | May 2008 - Present |
| Description: | Clean utensils, equipment, and the storage, food preparation and serving areas for the purpose of maintaining sanitary conditions
Implement menu plans for the purpose of meeting customers' requirements. Inventory food, condiments and supplies for the purpose of ensuring availability of items |
| Employer: | RCM Technologies, Inc - Elli Lilly, Guayama |
| Position: | QC Representative – Computer System Application |
| Time period: | July 2007 - Present |
| Description: | - Validate / Administrate QC Laboratory CSV system
- Develop or review validation life cycle documents such as CVP, URS, IQ, OQ, and CVR - Develop or review test scripts and or test cases - Develop or review system maintenance SOP’s - Develop or review system administration SOP’s - Conduct the periodic report review for the Laboratory CSV System and the corresponding reports. - Regulus Document Controller. - Prepare and/or print the Manufacturing Batch Records - Analytical Methods and Specifications Document Controller |
| Employer: | Wyeth Pharmaceuticals |
| Position: | Validation Specialist |
| Time period: | June 2009 - October 2009 |
| Description: | Shutdown projects: Requalification of Hydra Vial Washer, IMA Blue Galaxy Dry Heat
Sterilization and Depyrogenation Tunnel (hot zone and cool zone) and the qualification of the new OPT (optical particle counter) Performed temperature-mapping tests, using GE Kaye Validator 2000 Authored and executed of IQ, OQ, PQ, and CSV Protocols Organized meetings with clients to meet their satisfaction. |
| Employer: | Avocado Grill |
| Position: | Line cook |
| Time period: | August 2008 - December 2008 |
| Description: | Served as line cook in regionally recognized country club. Assembled food according to established guidelines, prepared food for grilling as well as salad preparation. Cooked food according to club recipes. Performed a wide range of kitchen duties. |
| Employer: | Oriental Validation Services - Wyeth, Guayama Site |
| Position: | QA APR Specialist |
| Time period: | September 2006 - June 2007 |
| Description: | - Development the Annual Product Review reports (Quality Components, Stability, Quality Unit, Salvage and Return, Test and Specifications, Commitment, LIR, MIR, Change Control, In Process Yield and others).
- Gather necessary information for the preparation of the Annual Product Review from various systems (LIMS, SAP, TrackWise, etc.). - Statistical evaluation for Annual Product Review, used Minitab, LIMS, SAP and TrackWise. Provide product recommendations. - Develop SOP and Element Report for Annual Product Review contribution. |
| Employer: | Taratec - Cordis LLC, San Germán, Puerto Rico |
| Position: | Computer System Validation Consultant |
| Time period: | December 2005 - September 2006 |
| Description: | - Generation and execution of Validation Protocols, Reports, Validation Master Plan, Customer Requirements for EMPOWER High Availability System.
- Develop and execute URS, FS, IQ, OQ, and PQ Validation Protocols for Empower High Availability System. - Ensure that validation activities comply with company policies, government regulations and GMPs. |
| Employer: | AstraZeneca - IPR Pharmaceuticals, Inc., Canóvanas, Puerto Rico |
| Position: | Quality Assurance Advisor |
| Time period: | December 2003 - November 2006 |
| Description: | - Review and approve the documentation generated as result of validation, modification or new product/technology introduction such as: Equipment Notification and Assessment form, Computer Validation Life Cycle, IQ, OQ, Experimentation Programs and Report, Process and Cleaning Validation documents and Laboratory Equipment Qualification.
- Participates in the required meeting to provide QA advice in the appropriate time frame during the different stages of the new and current projects. - Actively participating in the decision making process of QA issues related to start-ups, validation and qualification activities. - Review and approve the SOP’s generated or review as a result of a validation or modification of an equipment/system. - Internal GMP Audit. - Ensure that validation activities comply with company policies, government regulations and GMPs. |
| Employer: | AstraZeneca - IPR Pharmaceuticals, Inc., Canóvanas, Puerto Rico |
| Position: | Laboratory System Administrator |
| Time period: | December 2001 - November 2004 |
| Description: | - Administration and maintenance PeakPro and LIMS system.
- Administration and maintenance all laboratory data acquisition equipments. - Generation and execution of Validation Protocols |
| Employer: | AstraZeneca - IPR Pharmaceuticals, Inc., Canóvanas, Puerto Rico |
| Position: | SAP Project Implementation Team Member,( QM Module) |
| Time period: | December 1999 - November 2002 |
| Description: | - Support the SAP/LIMS Interface project development. Evaluation of application options, definition of business requirements, generation of validation documents, report status to management and system owners/users.
- Support the Information Systems Technology Team with regulatory documentation. - Develop training package for End Users. - Generation and execution of Validation Protocols. |
| Employer: | AstraZeneca - IPR Pharmaceuticals, Inc., Carolina, Puerto Rico |
| Position: | Chemist |
| Time period: | December 1995 - November 2001 |
| Description: | - Test finish product (for sales release), complaint, and stability samples
- Perform HPLC maintenance, troubleshooting, and minor repairs - Analytical support of process validations - Qualify new analysts - In charge of purchasing of laboratory materials and equipment - Revise laboratory standard operating procedures (SOPs) |
| Employer: | Chelsea Laboratories Caribe, Bayamón, Puerto Rico |
| Position: | Laboratory Analyst |
| Time period: | December 1994 - November 1996 |
| Description: | - Tested stability and raw material samples
- Performed HPLC maintenance, troubleshooting, and minor repairs |
EDUCATION
| University: | Universidad del Turabo |
| Time period: | 2002 |
| Degree: | Environmental Analysis, MSc |
| University: | Universidad Interamericana de Puerto Rico |
| Time period: | 1995 |
| Degree: | Chemistry, BSc |
INFORMATION
| Memberships: | Member of “Colegio de Químicos de PR” |
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Martha Pérez Allende
Puerto Rico, 33, majoring in Finance Keiser University love fashion and literature I like to help people to market their start ups