Participate in the preparation of annual budgets of the Company, ensuring that the department owns the material, human and information needed.
Coordinate the organization of the team/department so that the overall objectives are met
Develop monitoring indicators that are necessary in order to detect deviations and possibilities for improvement. In particular, ensure non stop production or sales activity for lack of analytical information.
Approve the operating methods of analysis and quality control procedures and general procedures affecting the Quality Control Department. Also ensure that personnel follow the approved procedures and methods.
Be responsible for implementing the corrective actions affecting the quality control department as a result of deviations or observations made manifest in an internal or external audit.
Support Quality Assurance during customer and Authorities inspections of Quality Control Activities.
In collaboration with other departments involved intervene in investigations arising from OOS or deviations that occur in the development of production.
Change Control Request
Approve validation protocols, production processes, stability studies, validation / certification of suppliers, analytical transfers, analytical methods as well as reports generated.
Plan analytical activities related to new products development and coordinate with other Departments the development of such activities. Approve documents related to the analytical development of drug products.
Provide technical assistance to supervisors, technicians and analysts in charge, and people from other departments upon request (claims assessment, validation, care audits, etc.).
Support Regulatory affairs in the response of deficiency letters or new dossiers submission in the activities related with Quality Control or Analytical Development.
Support customers in technical inquiries related to Quality Control.
Requirements and personal skills
Education: Degree in Chemistry, Pharmacy or other equivalent Sciences studies
Languages: High level of Spanish and English is a must.
Experience (years/area): Minimum 7-10 years of experience in management positions in Quality Control, managing teams, in the pharma industry.
Specific Knowledge: Knowledge of GMP and GLP regulations.
Travels: Open to travel
Personal skills: impact and influence, good communication skills, sensitive to detect errors and proactive to solve them.