IT Quality Computer System Assurance

hace 5 meses

Barcelona, España Ambit BST A tiempo completo

We are seeking a highly motivated and competent** IT Quality Computer System Assurance **to join our team and work together with our client, a multinational pharmaceutical company.

This role is crucial in ensuring the existence and compliance with common regulations and efficient and effective Quality Management processes/systems in the global IT Quality System Assurance scope. Additionally, you will be responsible for driving compliance with legal and regulatory requirements, as well as corporate compliance policies, when applicable, within the IT Quality System Assurance scope, including validation of cloud solutions.

**RESPONSABILITIES**:

- Ensure all deliverables meet regulatory requirements, including validation of computer systems and operational use, electronic records, data integrity, and signature requirements.
- Oversee the implementation and monitoring of efficient and effective computer quality processes related to quality.
- Support overall quality supervision and Corrective and Preventive Actions (CAPA) monitoring in the global quality IT scope.
- Promote a culture of quality and compliance within quality IT projects.
- Contribute to the continuous improvement of the quality standard:

- Monitor compliance with corporate regulations (policies, procedures, standard operating procedures, and work instructions).
- Coordinate and support external and internal audits/inspections related to corporate IT quality system assurance (e.g., by authorities or third parties).
- Monitor and evaluate the effectiveness of implemented CAPA measures.
- Provide proactive and effective consultancy and advice to support validation/qualification activities.

**WHAT WILL MAKE YOU SUCCEED IN THIS POSITION**:

- Profound experience in a GxP regulated environment (with a minimum of 3 years) with a focus on quality assurance and/or computer system validation.
- Excellent knowledge of international GMP requirements, Quality systems, Quality management (EU-GMP Guideline, 21 CFR 210/211, 21 CFR Part 11, Annex 11, ICH Q9, Q10, applicable GAMP and ISPE guides, etc.)
- Well-founded knowledge in MS-Office and regulated databases on the basis of SAP, Trackwise or Documentum
- Strong written and oral communication skills, ability to influence and manage upward, ability to work well in team environments.
- English: fluent
- Nice to Have
- German: helpful

**BENEFITS**:

- Permanent Contract.
- Ticket restaurant included in-office hours.
- Flexible Retribution Program (medical insurance, public transport ticket and childcare check)
- Discounts on gym network(AJ by Gympass)

**SCHEDULE**:

- From Monday to Friday: 08 am to 17 pm / 09 am to 18 pm (flexible)
- 1 day of office work | 4 days by remote.
- Location: Sant Cugat del Valles - Barcelona
- Our goal is that you are well in every way_

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