QA Systems Data Integrity Senior Lead

About the job

QA Systems Data Integrity Senior Lead Prothya Biosolutions makes life-saving plasma medicines and is proud of it! Every day, Prothya colleagues are delighted to go the extra mile to improve the health of millions of patients worldwide. Are you looking for a position at a flexible, fast-growing company with an interesting history? As owner of the Data Integrity Quality System. Ensure the accuracy, consistency, and security of data throughout its lifecycle in compliance with regulatory requirements, especially in regulated industries. Lead and oversee the Data Integrity program for all processes and activities at all Prothya departments (e.g. Automation, IT, Quality Control, Production, TSD, Warehouse, QA) from a QA point of view for both the NL and BE site. Act as an SME for data integrity during third party audits and inspections.

Your responsibilities:

1. Framework & Policy

• Write and review policies, procedures, and controls that ensure ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, and Available) are embedded throughout the organization.

2. Audit & Assessments

• Participate in internal audits and execute internal audits. Perform data integrity gap assessments and perform and lead risk assessments for all GMP processes and systems at Prothya.

3. Compliance Monitoring

• Ensure all GxP-related systems and processes comply with regulatory expectations and company policies regarding data integrity.

4. Training & Awareness

• Develop and deliver training and training materials to increase awareness of data integrity principles among staff across departments

5. Corrective and Preventive Actions (CAPA) and Change Control

• Investigate data integrity issues and lead the implementation of CAPAs in response to audit findings or deviations

6. Document Management

• Write, review and approve SOPs, and other documentation to ensure data accuracy and integrity.

7. Support Regulatory Inspections

• Act as a subject matter expert (SME) during regulatory inspections and client audits concerning data integrity

8. DI related projects and MOCs

• Act as a QA responsible in Data integrity related projects (e.g.g IT projects) and change controls

9. Reporting

• Develop, monitor and follow-up KPI’s on data integrity
• Provide DI input for the monthly and quarterly QMR

Your profile:

• Minimum Bachelor degree in science, pharmaceuticals, quality
• 3–6 years of experience in a GMP environment, ideally in pharmaceuticals
• Experience with Data integrity is a must
• Deep understanding of ALCOA+ principles
• Understanding of qualification and validation of Computerized Systems (CSV) and Equipment
• Familiarity with relevant guidelines: FDA 21 CFR Part 11, EU Annex 11, ICH Q9 (Risk Management) and Q10 (Pharmaceutical Quality System)
• Strong communication skills
• Stakeholder management

What we offer:

• Full-time employment (40h) with flexible working hours in consultation. Working part-time can be discussed.
• 8.33% end-of-year bonus and 8.33% holiday allowance.
• A personal training budget of €2,100 every three years to foster professional growth and development.
• Contribution to travel expenses from the first kilometer.
• Excellent accessibility by public transport and private parking available.
• A pension plan with Zorg & Welzijn, providing security for your future.
• A dynamic, safe, and challenging working environment with ample opportunities to grow, innovate, and learn, all while making a meaningful impact on the health of millions.

Acquisitie wordt niet op prijs gesteld. Prothya aanvaardt geen ongevraagde hulp van bureaus voor deze vacature. Toegestuurde cv's (in welke vorm dan ook) door bemiddelingsbureaus aan enige medewerker van Prothya zonder geldige schriftelijke zoekopdracht, worden gezien als eigendom van Prothya waarvoor op geen enkele wijze een vergoeding verschuldigd is.