Farmaforum Partnering Day 2025

18 Sept 2025 | Madrid, Spain

ELENA SUÁREZ DE PUGA

Account Manager

Técnicos en Calibración y Montaje, S.A

Basque Country, Spain

4 profile visits

Consultant & Account Manager partnering with TCM, supporting Pharma, Biotech and MedTech in regulatory compliance, including qualification & calibration service

My organisation

TCM, Técnicos de Calibración y Montaje, S.A., is a leading technical services company with more than 25 years of experience in the pharmaceutical, biotechnology, healthcare and industrial sectors. Since our foundation in 1998, we have specialized in industrial installations, calibration, validation and qualification, as well as preventive and corrective maintenance. Our independent status allows us to make decisions focused solely on our clients’ needs, delivering flexible, tailored solutions to ensure compliance, technical excellence and operational efficiency. With a highly qualified and experienced team, TCM is committed to precision, reliability and customer satisfaction. We support our clients in achieving full regulatory compliance with EU GMP, FDA and ISO standards, offering services that cover the complete life cycle of equipment and facilities. From calibration and qualification of instruments and controlled environments to industrial assembly and maintenance, our mission is to provide a professional and trustworthy service that consistently exceeds expectations. At TCM, we combine experience, technical expertise and a strong commitment to quality, making us the trusted partner for companies requiring robust technical support and regulatory compliance.
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About me

I am a pharmacist with more than 20 years of experience in the pharmaceutical, biotechnology and medical devices sectors. Throughout my career, I have held senior positions leading quality assurance, regulatory compliance, validation and auditing processes under EU GMP, FDA, ISO 13485, MDSAP and other international standards. I have successfully implemented and improved quality systems, risk-based approaches, supplier management, development of Deviation and CAPA processes, as well as training support for teams at all levels. My expertise also includes qualification, calibration, process validation and data integrity, together with the management of multidisciplinary teams and strategic projects. I have worked with sterile manufacturing processes, gaining solid knowledge of the applicable regulatory requirements. I combine technical knowledge with leadership and change management, and I have actively defended and supported companies during inspections by regulatory authorities and notified bodies. Passionate about quality, regulatory excellence and innovation, I am committed to supporting organizations in strengthening compliance, operational efficiency and global market access.

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Skills

  • Qualification, calibration, GMP and ISO 13485 SOPs

Interests

  • Equipment manufacturers, cleanroom engineering
  • Sterilization process validation
  • Ultra-freezer distributors
  • Incubators distributors
  • Autoclave manufacturer
  • Temperature mapping

Additional questions

Areas od activity

Pharmaceutical industry Laboratory industry Cosmetic industry

Organization type

SME

Marketplace (1)