These professionals follow the ISO quality regulations focused on the processes, Good Practice regulations (GLP/GMP/GCP) and the CE marking for the certification of medical devices in order to ensure that the actions carried out comply with requirements previously set forth by law and by the company's objectives, and that these actions can be reproduced, traceable, properly documented and that the staff is perfectly qualified to carry out the assigned tasks.

These professionals work in two areas: quality control and quality guarantee. They ensure the compliance of internal specifications with the standards and good manufacturing practices. The quality guarantee (define the framework and reference standards) and quality control (define the processes, internal verification systems and application of corrective actions). They must define the quality assurance strategy, the types of regulations which must be fulfilled, the allocated resources and the necessary checks on technical teams and staff.

• Supervise the drafting and updating of the SOP (Standard Operating Procedures) necessary to describe, organise and manage the processes under their responsibility.
• Write up validation protocols and coordinate the execution.
• Coordinate and carry out internal audits.
• Manage possible deviations and the resulting corrective actions.
• Manage the control of the changes carried out.
• Prepare all the documentation necessary to obtain quality certifications.
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• Carry out the analyses to control the quality of the raw materials and finished products.
• Assemble the devices, prepare the tests, conduct the tests, and analyse and communicate the results to the head office.
• Oversee the maintenance and functionality of the laboratory tools to ensure safety in the quality control process.
• Ensure regular control of the material and guarantee optimal working conditions.

Regulated training and graduates

• Professionalism Certificate: Microbiological and biotechnological tests (Level 3)
• Professional Training Course(s) in the field of Chemical Professional Families - Advanced Level: Laboratory for analysis and quality control
• Professional Training Course(s) in the field of Chemical Professional Families - Advanced Level: Pharmaceutical, biotechnological and Related Product Production
• Professional Training Course(s) in the field of Chemical Professional Families - Advanced Level: Chemical industry
• Grau: Biologia
• Grau: Biotecnologia
• Grau: Bioquímica
• Grau: Química
• Grau: Enginyeria en tecnologies industrials
• Grau: Enginyeria química
• Grau: Enginyeria de disseny industrial
• Grau: Enginyeria de disseny industrial i desenvolupament del producte

Complementary training

Knowledge of Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP), so it is essential to have specific training in this area.
Knowledge of the ISO standards is essential.
Knowledge of statistics.

Other specific skills

High level of English is required.

A minimum of one year of experience is required in Pharmaceutical Industry Quality Departments.

Flexibility and change management: Level 2

Strategic orientation: Level 2

Concern for order and quality: Level 3

Orientation within reach: Level 2

Planning and organisation: Level 2

Management

The organisation, administration and control of a company or entity are the main interests of people related to the management field. Activities included in this field of interest vary from effective resource management, feasibility analyses and solving business problems to the development of skills and fostering of motivation in relation to human resources. Knowledge regarding specific techniques of strategic administration and business management are required to carry out these activities.

Specialist in catalysis and catalytic processes

Chemical Laboratory Technician

Environmental and chemical safety specialist

Drug development technician.

Process controller

• Work hours

  Usually full-time job with flexible hours.

• Salary

  The salary ranges between 18,000 and 35,000 euros gross per year depending on the experience provided.

• Professional category

  Technician