Site Validations Coordinator

 Job Summary   The Site Validation Coordinator is responsible for execution and implementation of corporate validation initiatives at the site.  Additional responsibilities include developing and maintaining the Validation Master Plan, training and educating associates engaged in validation activities and developing a validation support structure and document handling system.  The site validation coordinator also has responsibility for tracking and reporting metrics associated with validation.



Duties and responsibilities



Local Implementation of Validation Toolkit

Publish site specific validation progress Reports

Develop and maintain Validation Master Plan (VMP)

Develop and maintain Validation Tracking Schedule (VTS) & Product and Process Table (PPT)

Ensure validation support structure and document handling system are developed and maintained

Host training and educational sessions appropriate for associates relevant to validation procedures.  Establish and maintain systems that track training and training records

Establish and maintain systems that track Validation records ie:  protocols, completion reports and total Validation Package

Establish mentoring process to improve effectiveness of validation work

Communicate site activities regarding validation

Support and influence change management at site:  Liaison between Core Team, Unit Program Managers and Unit Validation Champions

Develop and maintain validation procedures and related local records

Approve protocols and reports as needed

Develop and maintain metrics to measure progress

Work with Corporate Validation Services to sustain validation activities

Participate on unit validation coordinator team by attending bi-weekly conference calls and regular meetings

Participate in regulatory audits and inspections

If the SVC is also a Practitioner, Use lean, problem solving methods, and data analysis tools and techniques in validation efforts

Support site change control procedures

Participate in management review and Executive Steering Committee to report on Validation Status.

Keeps abreast of the basic requirements for compliance in own area of work and complies with those requirements. Participates as required in training on regulatory issues affecting own area of work. Brings regulatory compliance questions/issues to the attention of management.

Promotes a safe work environment. May provide recommendations on maintaining the safety of the work environment. Participates in Environmental Health and Safety programs. Addresses corrective actions whenever a hazard is identified. Notifies supervisor of all observed hazardous conditions or unsafe work practices.

Performs other related duties and assignments as required



 Knowledge and skills 


Green Belt Six Sigma Certification or equivalent (ASQ: CQE - Certified Quality Engineer ) and a practitioner of the certification for at least four years.

Strong technical, analytical, problem solving, and statistical background

Project Management skills

Knowledge of Lean and Six Sigma for Manufacturing

QSR/Manufacturing/Quality experience

Training and education skills

Knowledge of site manufacturing and analytical  processes

Demonstrate effective leadership.

Bilingual – English/Spanish.

Willing to travel to US and Mainland

Demonstrated ability to perform detail-oriented work with a high degree of accuracy.

Demonstrated ability to follow established policies and procedures.

Effective oral and written communication skills.

Effective organization and planning skills.

Effective analytical, quantitative, and problem solving skills.

Effective interpersonal skills


         EDUCATION AND EXPERIENCE

 
Typically requires a Bachelor of Science and a minimum of four years process validation experience on pharmaceutical, medical device or biotechnology manufacturing processes and equipment, or equivalent combination of related education and experience.