Quality Systems Specialist

Descripción del puesto:

• Quality Systems Specialist
• Madrid

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INSUD PHARMA operates across the entire pharmaceutical value chain, providing specialized knowledge and experience in scientific research, development, manufacturing, sales, 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.

The activities of INSUD PHARMA are organized into three synergistic business areas: Industrial (Chemo), Branded (Exeltis), and Biotech (mAbxience), with over 9,000 professionals in more than 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.

Ready to be a #Challenger?

What ar e we looking for? 🔎

General Responsability

The Quality Systems Specialist acts as the qualified functional link supporting the Global TrackWise Digital (TWD) team on technical Quality System aspects, ensuring the platform is configured, validated, and maintained in a compliant state. The role supports global TWD implementations and continuous improvement activities across sites, in alignment with Global Quality and IT standards.

The candidate will contribute to and/or support additional Global Quality Unit projects according to expertise and business needs. Key responsibilities include:

System governance, configuration & deployment

• Create and maintain global SOPs, work instructions, and standards related to TWD configuration and use.
• Provide configuration support for TWD modules (e.g., workflows, forms, fields, roles/permissions, notifications, reports) in line with global templates and governance.
• Support global rollouts/implementations, including site onboarding activities and alignment with local key users.

Validation, compliance & data integrity (CSV)

• Support the computer system validation lifecycle deliverables (e.g., URS, risk assessments, validation strategy, traceability, test script preparation/execution support, evidence review).
• Participate in validation of configured workflows and ensure proper documentation of changes and testing evidence.
• Ensure data integrity principles (ALCOA+) are applied in system use, configuration decisions, audit trail considerations, and reporting.

Change, incident & release management

• Support change control activities for system enhancements (impact assessment, testing requirements, stakeholder coordination, approval routing).
• Manage administration tasks via ticketing (incidents/requests), coordinating with IT partners and vendors, and following up on root cause analysis and CAPA where applicable.
• Support regression testing and release readiness activities related to Salesforce/TWD updates when applicable.

Data migration & master data activities

• Interact with local key users to collect, map, and validate key data to be migrated into the system.
• Participate in data migration activities including data cleansing rules, migration test cycles, and reconciliation/verification of imported data into Production.

Training, support & knowledge management

• Provide training and technical support to site key users and other stakeholders.
• Organize and deliver training, coaching, and support to junior technicians; contribute to a knowledge base (job aids, FAQs, troubleshooting guides).

Audits & inspections

• Support internal/external audits and inspections by providing system documentation, evidence packages, and responses related to TWD operation and validation status.

Key Responsabilities Education

• Degree in Science or related discipline. Master’s degree is a plus.

Languages

• Fluent in English and Spanish; additional languages are an asset.

Experience

• Minimum 3 years of experience in a similar Quality Systems / eQMS / digital quality application role.
• Pharmaceutical/regulated industry experience is strongly preferred.

Technical knowledge (preferred)

• TrackWise Digital experience is a strong plus; familiarity with Salesforce-based platforms is an asset.
• Good understanding of GxP requirements and computerized system validation concepts (e.g., 21 CFR Part 11 / EU Annex 11; risk-based validation).
• Proficient in MS Office (Word, Excel, PowerPoint); experience with reporting/analytics tools is a plus.

Travel

• Willingness to travel as required by project needs; however, only limited travel is expected.

Our benefits!

1. ⏰ Flexible start time from Monday to Friday (full-time).

2. 📜 Permanent contract.

3. 🥼 Life and accident insurance.

4. 🍽️ Ticket restaurant

5. 🥼 On-site medical service

6. 💸 Benefits and Savings Club.

7. 💻 Training and language learning platform

8. 💆🏻 ♀️ Wellness platform with unlimited free psychologist sessions

9. 📈 Development plans, internal mobility policy.

10. ⭐ Many more!

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COMMITMENT TO EQUAL OPPORTUNITIES

The InsudPharma group is aware that business management must align with the needs and demands of society, and therefore assumes the commitment to equal opportunities and treatment between men and women, as stated in the current regulations on the matter - Organic Law 3/2007, and we do not discriminate against any person on the grounds of ethnicity, religion, age, sex, nationality, marital status, affective or sexual orientation, gender identity or expression, disability, or any other personal or social circumstance.