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Quality Assurance Specialist

Quality Assurance Specialist

 

Develops and implements programs to establish and maintain quality standards of existing products and services, as well as developing programs to focus employees on quality improvement. Develops policies, procedures and methods to check product, material, components and/or operational quality and improve same.

 

Education

Pharmacist graduate degree

 

Work experience

  1. Requires some relevant professional experience (approximately 3-5 years as a guide).
  2. Experience across various therapeutic indications, chemical and biologic drugs and devices.
  3. Established expert knowledge either in therapeutic area or technical area: Quality Assurance and other quality related areas 
  4. In-depth technical knowledge and in-depth knowledge of local regulatory requirements
  5. Excellent English and local language communication skills (oral and written) and demonstrated ability to effectively share information and any proposals with management, peers and others

 

Key accountabilities

  1. Expands competences by performing structured work assignments according to existing procedures
  2. Resolves problems of limited complexity by identifying and selecting solutions through the application of knowledge and acquired technical experience and the analysis of information
  3. Acquire and update quality standards in the frame of general guidelines
  4. Create and review QS-relevant documents
  5. Create and maintain a documentation system for process documentation

 

Job specific competencies and skills

  1. To manage artwork process to implement artworks in the CMO (Contract Manufacturing) manufacturing

  2. To maintain artworks and shelf life databases and support Country RA teams with them
  3. To update and maintain documentation to support quality and regulatory activities to CMO manufactured products
  4. Manage the change control process of the subsidiary
  5. Manage the risk management process of the subsidiary
  6. Manage the annual product review program of the subsidiary
  7. To conduct documentation requirements from exporting countries, in order to get, renew, and/or modify Marketing Authorizations (MA) according to legal and technical requisites according respective Heath Authorities (HA 
  8. Contribute and review standard operating procedures (SOPs) in charge; ensure SOPs are in compliance with current regulatory requirements and provide regulatory and quality support for corporate.
  9. Excellent interpersonal, organizational, problem solving and leadership skills
  10. Structured approach to working tasks and problem solving.
  11. Able to manage projects independently in time constrained situations.
  12. Ability to work independently and successfully within a multidisciplinary and multicultural team environment
  13. Ability and willingness to travel internationally

 

 

 

Job Requisition ID:  197333
Location:  Distrito Capital de Bogotá- al
Career Level:  D - Professional (4-9 years)
Working time model:  full-time

US Disclosure
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.  This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.


Job Segment: QA, Quality Assurance, Quality, Technology

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