Quality Assurance Specialist

Fecha: 06-dic-2018

Location: Montevideo, MO, UY

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Requisition ID: MAN005793

MSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where MSD has codified its 125-year legacy. MSD’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

 

Position Objectives:

Responsible for ensuring products quality meeting the established standards of quality in accordance with applicable regulations.

 

Main Responsibilities: 


  • Technical representative of the Company coordinates and manages the relationship with regulatory agencies in accordance with the Technical Director, including all necessary procedures for the operation of the laboratory.

  • Collaborate with product local registrations, including filling out and signing the corresponding forms as well as renewal of registrations.

  • Collaborates in the preparation of registration documentation for other countries as required.

  • Interpret and implement quality standards and review the implementation and efficiency of quality and inspection systems as well as identify training needs and organize training interventions to meet quality standards. Assure ongoing compliance with quality and industry regulatory requirements

  • Participate on internal investigations. Recommend and monitor corrective and preventive actions

  • Prepare reports to communicate outcomes of quality activities

  • Coordinate and support on-site audits conducted by external providers and participate and document internal audits. Evaluate audit findings and implement appropriate corrective actions.

  • Responsible for document management systems.

  • As continues improvement of the position is required the QA Manager after proper qualification and training to assumes technical responsibilities as provided in the figure of Technical Director in Decree 160 / 997

  • The QA Specialist is responsible to ensure the correct execution of all safety testing, which he or she performs as an internal service for the Department of Quality Control in coordination with the Quality Control Manager. Included in this task is the search for and authorization of appropriate field establishments.

  • Responsible for the health of animals in all respects. Monitoring and controlling the health of animals, researching and diagnosing conditions and determining measures to be taken.

  • Participates in the performance of biotests, collaborating technically to the extent necessary and providing technical advice in order to ensure the reliability of testing. Responsible for investigating and reporting, from a veterinary point of view, all abnormal circumstances.

  • Provides advice internally on all aspects related to the veterinary profession. Instances of internal advice may arise in relation to marketing needs in the course of the development of a product.

  • Must offers external advice on issues related to our products to our customers or end consumers when this is required, managing complaints.

  • Participates in discussions related to product development and contributes with technical opinions.

  • After proper qualification and training QA Specialist shall assumes the technical Director representation of the Company in areas where this is necessary (Chamber of Veterinary Specialties, various events, receiving visits, business trips). draft quality assurance policies and procedures

  • Interpret and implement quality standards and review the implementation and efficiency of quality and inspection systems as well as identify training needs and organize training interventions to meet quality standards. Assure ongoing compliance with quality and industry regulatory requirements

  • Participate on internal investigations. Recommend and monitor corrective and preventive actions

  • Prepare reports to communicate outcomes of quality activities

  • Coordinate and support on-site audits conducted by external providers and participate and document internal audits. Evaluate audit findings and implement appropriate corrective actions.

  • Responsible for document management systems.
Qualifications

Qualifications & Experience

Education:


  • Doctor in Veterinary Medicine

  • Fluent in English, oral and written

Experience:


  • Desirable: Up-to-date on biotechnology, particularly in the area of vaccines

  • Able to register for the function with the Competent Authority assuming technical responsibility in all aspects.

  • Understanding of GMP


Job: Manuf./Operations Generic
Other Locations:
Employee Status: Regular
Travel:
Number of Openings: 1
Shift (if applicable):
Hazardous Materials:
Company Trade Name: MSD

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