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Computerized Systems Validation (CSV) Expert

Computerized Systems Validation (CSV) Expert

Polpharma BiologicsDuchnice (pow. warszawski zachodni), Masovian, Poland
4 days ago
Job description

responsibilities :

  • Define, plan, and report CSV activities in alignment with regulatory expectations (e.g. FDA 21 CFR Part 11, Annex 11).
  • Review and approve validation documentation (e.g. URS, risk assessments).
  • Support of the CSV activities in the main CSV areas : Production Systems, Enterprise Systems Laboratory Systems.
  • Support CSV activities by monitoring progress and escalating risks to ensure smooth business operations.
  • Collaborate with users, subject matter experts, and suppliers to plan and implement validated systems.
  • Review and approve key technical and quality documentation, including user requirements for computerized systems.
  • Assess and define the level of validation required following system changes.
  • Identify systems in scope for validation using a risk-based approach.
  • Ensure risk-based approach to system validation and changes.
  • Participate in internal and external audits, representing the QA CSV area.
  • Provide guidance and training to site personnel on CSV requirements and data integrity.
  • Monitor project progress and escalate risks to ensure timely delivery.
  • Continuously develop your expertise in CSV and digital quality assurance trends.
  • Initiate and review digital actions in TrackWise (deviations, change controls, CAPAs).

requirements-expected :

  • Minimum 5 years in pharmaceutical or biotech industry.
  • A degree in Biotechnology, Pharmacy, or a related field.
  • Strong understanding of cGxP, data integrity, and validation of automation systems.
  • Proven experience in : Computerized Systems Validation, Equipment Qualification (Production and Laboratory) and QA documentation and lifecycle management.
  • Participation in internaI and external audits through presentation of CSV topics to interna! auditors as well as Polish and Foreign Health authorities.
  • Ability to work independently and collaboratively across departments.
  • Excellent communication and decision-making skills.
  • offered :

  • Competitive salary.
  • Private healthcare.
  • Life insurance.
  • Pension plan above national standards.
  • Additional free day.
  • and more..
  • benefits :

  • sharing the costs of sports activities
  • private medical care
  • sharing the costs of professional training & courses
  • life insurance
  • retirement pension plan
  • coffee / tea
  • extra social benefits
  • pre-paid cards
  • holiday funds
  • christmas gifts
  • employee referral program
  • extra leave
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