Are you passionate about cutting-edge biotechnology and eager to play a pivotal role in computerized systems validation. As a QA CSV Expert, you will be responsible for delivering quality oversight for the validation of computerized systems throughout the entire system lifecycle. From URS to decommissioning, your work ensures compliance with global regulatory requirements and supports critical business operations in Production, Enterprise, and Laboratory systems.

Your responsibilities include, but are not limited to:

• 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).

If you have:

• 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.

What we offer:

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