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Validation and Qualification Technician

On-site in Azuqueca de Henares·Added yesterday (last checked 3 Nov)

Insud Pharma

64 open roles

Our summary

Work mode
On-site, Azuqueca de Henares
Contract
Permanent
Spanish
Fluent
English
Required
Experience
3+ years
Education
University degree
Benefits
Life insurance

Visa options

  • The ad rules out sponsorship

    The advert says visa sponsorship isn’t available for this role.

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Skills

This job advert was originally written in Spanish.

Requirements

What we're looking for

Experience: 3 to 4 years in similar roles.

  • University degree in Pharmacy, Chemistry, Chemical Engineering, or similar.
  • Fluent in Spanish and English.
  • Between 3 and 4 years of experience in Validation, Technical Services, Quality Assurance, or Production departments within the pharmaceutical industry.
  • Solid knowledge of GMP regulations, both European and FDA.

Nice to have

  • Experience in injectable product manufacturing plants will be especially valued.

Pay & benefits

What you'll get

Our benefits!

💸Attractive salary package.

🥼 Life and accident insurance.

🍽️ Company canteen (free).

🥼 Copayment on voluntary health insurance.

💸Benefits and Savings Club.

📈Development plans, internal mobility policy.

The role

Position: QA Validation and Qualification Technician (CSV/CQV)

Location: Azuqueca de Henares.

The QA Validation and Qualification Technician (CSV/CQV) will work in the plant's Quality area.

The challenge!

What you'll do

Guarantee the maintenance of the qualification status of equipment, facilities, and services, as well as the validation status of processes associated with the manufacturing of injectable products, including manufacturing processes, aseptic processing, cleaning, and conditioning, in accordance with applicable regulations and established quality standards.

  • Collaborate in the preparation of technical documentation associated with qualification and validation activities, including protocols and reports.
  • Execute the necessary tests for the qualification of production equipment, such as formulation, filling, and conditioning.
  • Develop protocols, reports, and tests for the qualification of facilities, equipment, and systems.
  • Design and execute the necessary activities for the validation of manufacturing processes.
  • Prepare and execute cleaning validation protocols and reports.
  • Develop aseptic process validation protocols and reports (media fill) and participate in their execution.
  • Review validation protocols and reports carried out by internal or external personnel, guaranteeing the correct execution of activities and compliance with established requirements.
  • Participate as an expert in external audits and inspections.
  • Ensure the correct filing and maintenance of validation documentation.
  • Manage the qualification of visual inspection sets.
  • Manage quality systems linked to qualification and validation activities, such as deviations, change controls, and CAPA plans.
  • Train and support new hires in those activities and functions of the position in which they act as a technical reference.

How you'll work

📜Permanent contract

What do you need?

⭐And much more!

About Insud Pharma

Industry
Pharmaceuticals

In their own words

About the company & team

INSUD PHARMA operates across the entire pharmaceutical value chain, providing specialized knowledge and experience in scientific research, development, manufacturing, sale, and marketing of a wide range of active pharmaceutical ingredients (API), finished dosage forms (FDF), and branded pharmaceutical products, adding value to human and animal health.

INSUD PHARMA's activity is organized into three synergistic business areas: Industrial (Chemo), Branded (Exeltis), and Biotech (mAbxience), with more than 10,000 professionals in over 50 countries, 20 state-of-the-art facilities, 15 specialized R&D centers, 12 commercial offices, and more than 35 pharmaceutical subsidiaries, serving 1,150 customers in 96 countries worldwide. INSUD PHARMA believes in innovation and sustainable development.

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