Quality Assurance CSV Manager

il y a 3 semaines

Paris, Île-de-France Scienta Temps plein

Job Title: Group Information Systems Validation and Data Integrity Quality Manager

Main Responsibilities:

Information Systems (IS) Validation:

  • Define and implement the group's strategy for the validation of computerized systems in compliance with current regulations (GxP, 21 CFR Part 11, Annex 11, ISO 13485, etc.).
  • Ensure the compliance of IT systems (ERP, LIMS, eQMS, RIM, etc.) with quality and regulatory requirements.
  • Coordinate and oversee IS validation activities (writing and approving validation documents, testing, periodic reviews, etc.).
  • Provide pragmatic support to various sites for implementation (training and guidance), define deployment plans, and monitor progress.
  • Collaborate with IT and business teams to ensure the integration of quality requirements from the project design phase.
  • Assist site teams, particularly the Mérignac site, in executing actions related to computerized systems validation and Data Integrity development. Ensure the annual update of computerized systems validation plans or associated action plans and risk analysis strategies. Keep site management informed of progress and any deviations or difficulties encountered.

Data Integrity:

  • Develop and implement a data integrity governance program across all critical IT systems and processes.
  • Train and raise awareness among teams about Data Integrity best practices.
  • Conduct internal audits and compliance assessments to identify gaps and propose corrective action plans.
  • Act as the key point of contact during regulatory inspections on IS validation and Data Integrity topics.

Continuous Improvement and Regulatory Monitoring:

  • Monitor regulatory and technological developments in IS validation and Data Integrity requirements.
  • Contribute to the continuous improvement of validation and data management processes by integrating industry best practices.
  • Participate in internal working groups and professional networks related to computerized systems quality.

Profile:

Education:

Master's degree (Bac+5) in Pharmacy, Engineering, IT, or Quality with a specialization in IS validation and Data Integrity.

Experience:

Minimum of 5 to 8 years' experience in computerized systems validation and/or data integrity management in a pharmaceutical environment.

Technical Skills:

  • In-depth knowledge of regulations (Annex 11, 21 CFR Part 11, GAMP 5, Data Integrity ALCOA+).
  • Experience in IS validation in a GxP environment.
  • Proficiency in project management methodologies and validation tools.

Behavioral Skills:

  • Strong analytical skills and attention to detail.
  • Leadership and ability to unite cross-functional teams.
  • Excellent communication and change management skills.
  • Professional-level English is essential.

Internal and External Interactions:

Internal: IT, Quality Assurance, Production, R&D, Regulatory Affairs, Manufacturing

External: Inspectors or Auditors, IT solution providers, auditors, consultants

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