Kevin Del Valle Email & Phone Number

Copenhagen, Dk

Copenhagen, Capital Region Of Denmark, Denmark

Copenhagen, Capital Region Of Denmark, Denmark

As a Lean Specialist at Operational Excellence my responsibilities were.• Visual management• Leadership coaching • Process assessments with identification of improvement potential and the realization of these• Complex data analysis• Engage the organization through coaching to continuously spread operational excellence to my co-workers• Supporting of projects where ways of working and collaboration are areas of interest

Copenhagen, Capital Region, Denmark

Responsible for the API production with profound experience within GMP guidelines, aseptic processing and Annex 1 guidelines.• Environmental monitoring excursion handling• Deviation, CAPA and change control handling• Aseptic process optimization and LEAN activities• Development, optimization and implementation of MPCR's, SOP's, work instructions and other GxP records• Process simulation support• Continuous aseptic training of department operators• Audit/inspection responsible. Presentations for customers and authorities • Classification of cleanrooms

Copenhagen Area, Capital Region, Denmark

• Deviation, CAPA and Change Control handling• Batch review• Environmental monitoring review• Process optimization and lean activities ensuring improvement of batch release lead times in collaboration with Operational Excellence department.• Elaboration of work instructions and revision of SOP's.• Continuous GMP training of Final Handling, API department operators along with Manufacturing Support team.• Ensure timely batch release in collaboration with production and MQA department.

Copenhagen Area, Denmark

Sterile operator (6 months):• Final Handling, API (Freeze Drying department)• Development, manufacturing and supply of API's and FDF's• SmartPak, Innovative packaging system, for large volume sterile product preparationEngineering & Sterility Assurance Operator (1 year):• Expansion of existing Freeze Drying department• Defining and dimensioning constructions, along with design of process equipment• Proper and timely implementation of new production and utility equipment• Improvement of compliance level to meet current regulatory requirements, in relation to cGMP and EHS• Execution of DQ, FAT/SAT• Qualification/Validation• Global API manufacturing

Copenhagen Airport

• Comprehensive and strategic planning of daily team oriented task• Head of operational tasks of up to 5-6 co-workers• Quality control• Job trainer

Basic Management Education

Certified Lean Six Sigma Green Belt

Math B, Mathematics, 10

Education record