Customer Service Quality

Virginia Castro Toro

Urb. Praderas calle Andalucita # 39 Gurabo, P.R. 00778

787-***-**** ********@*****.***

Summary of Qualification

Background in Chemistry includes Quality, Total Quality, Lean Sigma. Highly

self-motivated, well organized and fast learning individual and team work

oriented, flexible to business needs and people oriented. Knowledge and

strong working experience in Word, Excel, and Power Point Microsoft, Lotus

Notes, Outlook, Track Wise System, ISOtrain XP System and LIMS.

Accomplishment

. Conducted several training programs for quality system area reducing

customer complaints with the application that we used to revise the

procedures.

. Empowered with the document management system during consent decree

resulted in a successful implementation of more than three hundred

regulatory documents.

. Improved office efficiency and customer service by redesigning the pickup

of documentation and filing system.

. Supported all remediation projects in the areas of manufacturing,

packaging, engineering, quality, in general throughout the plant,

resulting in timely delivery of projects', which got awards in the

company.

. Facilitated the launch of new products with my cooperation and

organization of projects in the laboratory area.

. Created ways to measure the effectiveness in the document control system,

which resulted in the creation of a tool in Excel that resulted in 100%

compliance.

Professional Experience

Quality Consultant

2008 to Present

. Established supplier audit, document control and ISO certification

programs.

. Planned inspection techniques and systems to ensure consistent

activities.

. Coordinated and Managed successful training and auditing programs.

. Knowledge in QSR, ISO, GMP regulations.

. Create Quality and process procedures

. Establish procedures for compliance audit for vendors and suppliers

GlaxoSmithKline, Cidra, Puerto Rico

Quality Standard Professional

2003 to 2007

. Administrate the Standard Operating Procedure and Validation Protocol

Systems.

. Manage, Audit, Revise existing and/or develop and implement all changes

in the SOP system.

. Experience with electronic document management systems.

. Understanding and Support the approval and closure of Quality Systems

such as Change Control, Deviation/CAPA, NOE, Production Controls, Material

Controls, Facilities/Equipment Controls, and Laboratory Controls.

. Ability to interpret GMP requirements and provide guidance to others in

the context of Document Control and establish document control processes

and procedures for GMP and GLP practices.

. Supervised the activities of other personnel with general direction.

Responsible to lead, plan, organize and supervise one or more person

assign to different task. Back up for Quality Standard supervisors or

manager when required.

. Actively participate in Operational Excellence activities to improve

operations related to document management area and participate in local

quality improvement groups, relevant functional/technical meetings to

provide advice.

. Reviewed first level deviations reports, such as Notifications of Events.

. Conducted field verifications of CAPA implementations.

. Supported in Central Archival administration.

. Identify, make metrics and report records management problems and

discrepancies.

. Actively participated and provide documentation support to internal,

corporate and external regulation inspections and audits.

. Participated in the self - inspection process for the assigned area

(s)/system (s), including the execution of corrective and/or preventive

actions.

Documentation Specialist 2002 to 2003

. Verificated and approved manufacturing batch records.

. Knowledge in tablets manufacturing; compression, coating and granulation

areas.

. Performed documentation evaluation related to water usage in sterile

area.

. Evaluated and close special disposition for materials.

. Generated commercial release documentation for validation lots.

. Prepared monthly and annual reports related to documentation.

. Performed internal evaluation to answers on documentation

deviation/observations and follow through on corrective actions.

. Reported any potential quality issue to upper QC/QA management prior to

batch disposition.

Education

Universidad Del Turabo, Caguas, Puerto Rico

Master Business Administration, Major in Quality Management

Universidad Del Turabo, Caguas, Puerto Rico

Bachelor of Science Degree, Major in Chemistry

Seminars / Trainings

Train the Trainer, Technical Writing, Advocate for Excellence, Leading

Edge, Auditing Techniques for Self inspection, Management Principles.

Contact this candidate