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Pharmaceutical Tecnical Manager for GMP Production Line


  • Location: San Sebastián (Spain)
  • Vacancies: 1
  • Discipline: R&D

CIDETEC

Would you like to build the future? Join CIDETEC! CIDETEC is a technology centre that brings together three leading international centres in the fields of Energy Storage, Surface Engineering and Nanomedicine. For more than 25 years, we have been working with leading companies to develop technology that makes the world a better place.

 

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Job description

     CIDETEC needs to hire a Pharmaceutical Technical Director for its drug manufacturing plant.

     The person hired will take charge of the technical management of the plant, guaranteeing the observance of proper manufacturing standards and releasing the batches manufactured in the plant.

Requirements

Education:

     BS in Pharmacy.

Languages:

     High level of spoken and written English.

Knowledge and experience:

     The person to be recruited must show solid knowledge of pharmaceutical regulations and GMP environments, apart from having at least 4 years of experience as Quality Assurance In-charge / Technical Manager.

Remarks: 
     We require a proactive, resolute, results-oriented and client-oriented person with capabilities for management, leadership, planning/organisation, teamwork, analysis and vision.

Functions:

     The person hired shall take charge of a pilot-scale plant for manufacturing drugs under GMP conditions.

     His/her functions will be:

  • To ensure proper conditions to guarantee that the drugs are manufactured, manipulated, stored and distributed in such a way as to ensure that their quality is maintained up to expiry.
  • To conduct initial and continuous management analyses on quality risks.
  • To review all the technical documentation of batches (batch records) prior to batch release.
  • To prepare the annual plan of internal audits and lead the team that will conduct the pertinent audits.
  • To manage the system of recording and monitoring deviations, inspect changes, attend to claims and corrective and preventive action as well as monitor these processes.
  • To prepare and monitor the quality indicators of the corporate Quality Assurance Department.
  • To ensure that each individual batch has been manufactured and inspected in accordance with the laws in force, in keeping with the requirements of their Marketing Authorisation and the standards of Good Manufacturing Practice (GMP).
  • To authorise the market release of each drug batch once compliance with the authorised specifications is certified.
  • To attend to regulating agencies in the course of inspections.

Compensation:  

     Based on candidate qualifications.

Recruitment availability:

     Immediate

Job closed

  • Location: San Sebastián (Spain)
  • Vacancies: 1
  • Discipline: R&D