Validation and Qualification Technician

About Litek Pharma

We are in continuous development and search for talent to join our team, are you interested?

The keys to the success of our company are understanding the uniqueness and needs of each project, offering solutions adapted to these needs and our capacity for innovation. Working at Litek Pharma means being part of a team with extensive experience in the pharmaceutical industry and a great passion for what we do.

We are looking for people who want to contribute to the success of the company. So, if you enjoy working in a team, you are flexible, adaptable and you like to take on new challenges, join us!

Job Description for Validation and Qualification Technician in Litek-Pharma

The Validation and Qualification Technician is responsible for qualifying equipment in compliance with pharmaceutical quality standards and Litek’s internal quality regulations, ensuring the conformity and quality of the equipment and installations delivered by the company. Key responsibilities include:

  • Ensuring the quality of Litek projects, both in-house and outsourced, by conducting internal inspections, FAT (Factory Acceptance Tests), and qualifications.
  • Drafting and executing qualification protocols such as FDS/DQ, FAT, SAT, IQ/OQ, etc., both at Litek and on-site at the client’s facilities.
  • Gathering, negotiating, and reaching agreements on client requirements within qualification protocols.
  • Attending FAT execution of assigned projects in collaboration with the client.
  • Continuously improving validation documentation and updating standards adapted to each project.
  • Requesting and managing quotes for external qualifications. Approving external protocols and supervising contracted work.
  • Supporting the acquisition, maintenance, and safekeeping of documentation related to pharmaceutical regulations.
  • Assisting in defining, maintaining, and filing calibration plan records for measuring instruments used in testing.
  • Managing the custody of measurement instruments.

How a Validation and Qualification Technician in Litek-Pharma is

Education

  • Higher Vocational Training (CFGS) in Chemistry, Laboratory, Quality Control, or a related field is required.

 

Experience and Knowledge

  • At least 2 years of experience in a similar role is required
  • Knowledge of the UNE-EN ISO 9001:2015 standard is required
  • Familiarity with international GMP regulations (European GMP and FDA GMP) is a plus.

 

Languages

  • A minimum C1 level of English is required.

 

IT Skills

  • Experience with Solid Edge is required
  • Proficiency in Microsoft Office is required.

 

Skills and Competencies

  • Planning and organizational skills
  • Customer orientation (both internal and external)
  • Results-driven and committed to continuous improvement
  • Teamwork
  • Analytical and problem-solving skills

What we offer you at Litek Pharma

  • Work in an industry in continuous development and for leading clients of different nationalities
  • Join a team of experts in technology solutions for the pharmaceutical industry.
  • Develop a career with a future and continuous learning.