North Highlands CA 95660
Qualified Validation Manager seeking a position in which to put my communication skills and experience to work for right company.
Highlights of Qualifications:
- Certification in writing analysis and review
- Experience in validation of GMP drug manufacture and managing a team of professionals
- Operational knowledge of data collection
- Exceptional knowledge of all pharmaceuticals rules and standards
- Immense ability to present accurate written reports
- Ability to analyze and resolve all conflict
- Amazing communication skills
- Skilled to interpret all validation requirements
- Proficient in understanding all guidelines for GMP facilities
- Outstanding understanding of validation principles
Allergan, Inc, Parkersburg, WV
October 2008 – Present
- Monitored all systems and units and ensured its qualification to be validated.
- Managed qualification program in accordance to necessary protocol.
- Evaluated all data and ensured implementation of all qualification.
- Reviewed and approved preventative maintenance and critical systems.
- Organized actions required for requalification of specific machines.
- Assisted other departments in purchasing machines and systems
- Trained various departments in qualification activities
- Developed Validation Master Plan.
Becton Dickinson, Parkersburg, WV
May 1998 – July 2003
- Managed all validation work according to Good Manufacturing practices.
- Developed all validation related documents.
- Coordinated with packing, manufacturing and Quality Control departments on all validation activates.
- Monitored all projects regarding validation process.
- Prepared validation plan and provided necessary support to all strategies.
- Assisted others by presenting data in layman format.
NewAgeSys, Inc., Parkersburg, WV
August 2003 – September 2008
- Developed and summarized all validation protocols for pharmaceutical manufacturing units.
- Documented all validation plans and protocols and ensured products met required needs.
- Reviewed validation requirements and developed strategies to prevent reoccurrence of problems.
- Oversaw working of validation tests on new products and validating cleaning process.
- Coordinated with various departments and implemented all validation activities.
- Provided technical support to validation staff when required.
Bachelor’s Degree in Engineering
Rockhurst University, Kansas City, MO