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ATMP QA Release Officer

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Novartis

6d ago

  • Job
    Full-time
    Junior Level
  • Healthcare
  • Barcelona

AI generated summary

  • You need a Pharmacy or related degree, 2+ years in pharma (QA/QC), preferably with ATMPs, strong analytical and communication skills, and fluency in English and Spanish.
  • You will support Qualified Persons, review batch documents, ensure GxP compliance, handle product complaints, manage deviations, maintain quality agreements, and participate in audits and inspections.

Requirements

  • Education: Degree in Pharmacy preferred, or related Health Care degree.
  • At least 2 years of demonstrated experience in pharmaceutical industry, in manufacturing, QA and QC. Preferable experience in Advanced Therapy Medicinal Products.
  • Analytical thinking, flexibility in working with other functions, country organizations, as well as the ability to solve problems.
  • Organizational talent, persuasiveness and the ability to communicate across departments (also internationally).
  • Fluent English and Spanish, written and spoken.

Responsibilities

  • Support of the Qualified Person(s) in the field of ATMPs (commercial goods and clinical investigational preparations) as well as in the supervision of clinical trainees in accordance with §3 of the Licensing Regulations for Pharmacists.
  • Compilation and preliminary review of documents from databases.
  • Execution of the batch record review of the manufacturing documentation.
  • Compliance with GxP requirements and other legal regulations in EU as well as participation or implementation of GxP training / SOP training.
  • Contacts/exchange of information with national and international functions (including CGT US, CGT CH, QA, supply chain, responsible persons in the countries, depot).
  • Archiving of documents for clinical investigational medicinal products.
  • Evaluation of pharmaceutical product complaints.
  • Documentation and evaluation of deviations.
  • Preparation and maintenance of quality accrual agreements.
  • Regular contacts with Novartis manufacturing companies and third-party manufacturers.
  • Participation in audits and inspections.

FAQs

What is the primary responsibility of the ATMP QA Release Officer?

The primary responsibility of the ATMP QA Release Officer is to assist the Qualified Person in maintaining and developing the quality assurance system as well as in the preparation and review of relevant documents for the release of medicinal products.

What qualifications are required for this position?

A degree in Pharmacy is preferred, or a related Health Care degree is acceptable. Additionally, candidates should have at least 2 years of demonstrated experience in the pharmaceutical industry, particularly in manufacturing, QA, and QC.

Is experience in Advanced Therapy Medicinal Products (ATMPs) important for this role?

Yes, experience in Advanced Therapy Medicinal Products is preferable for this role.

What languages must a candidate be fluent in for this position?

Candidates must be fluent in both English and Spanish, written and spoken.

What kind of working environment does Novartis promote?

Novartis is committed to building an outstanding, inclusive work environment and creating diverse teams that represent the patients and communities they serve.

What are the major accountabilities of this role?

Major accountabilities include supporting the Qualified Person(s) in ATMPs, compiling and reviewing documents, executing batch record reviews, ensuring compliance with GxP requirements, and participating in audits and inspections.

Are there opportunities for professional development?

Yes, Novartis offers learning and development opportunities as part of their benefits and rewards.

What is the location of the ATMP QA Release Officer position?

The position is located in Barcelona, Spain.

Does Novartis provide health insurance?

Yes, Novartis provides health insurance as part of their benefits package.

Is this position full-time or part-time?

This position is full-time.

Science & Healthcare
Industry
10,001+
Employees

Mission & Purpose

Novartis is reimagining medicine to improve and extend people’s lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the world’s top companies investing in research and development. Novartis products reach nearly 800 million people globally and we are finding innovative ways to expand access to our latest treatments. Around 108,000 people of more than 140 nationalities work at Novartis around the world.

Culture & Values

  • Inspired

    Engage our people. Strive for patients. Live our purpose

  • Curious

    Learn. Be open. Be self-aware

  • Unbossed

    Create clarity. Serve others. Own your actions

  • Integrity

    Be honest. Have courage. Do what’s right