QA Computerized Systems Senior Specialist

You will ensure that computerized systems supporting manufacturing, laboratory operations, and enterprise-level processes are compliant with applicable regulatory requirements (e.g. FDA 21 CFR Part 11, EU Annex 11). You will play a key role in the planning, execution, and documentation of validation activities.

Your key responsibilities:

• Define, plan, and report CSV activities in line with regulatory expectations.
• Review and approve validation documentation (e.g. URS, risk assessments, test protocols).
• Support CSV efforts across key areas: Production Systems, Laboratory Systems, and Enterprise Systems.
• Monitor validation project progress and escalate risks to ensure smooth implementation.
• Collaborate with system users, subject matter experts, and software vendors to implement validated solutions.
• Assess and define the appropriate level of validation required following system changes.
• Identify systems requiring validation using a risk-based approach.
• Represent the QA CSV function during internal and external audits.
• Train site personnel on CSV requirements and data integrity principles.
• Initiate and review quality actions in the TrackWise system (deviations, change controls, CAPAs).
• Continuously develop your knowledge in the areas of CSV and digital quality assurance.

Our expectations:

• Minimum 3 years of experience in the pharmaceutical, biotechnology, or related regulated industry.
• A degree in biotechnology, pharmacy, chemistry, engineering, or a related scientific/technical field.
• Strong understanding of cGxP requirements and data integrity principles.
• Proven experience in computerized systems validation (CSV), equipment qualification (production and lab), and quality documentation lifecycle
• management.
• Experience participating in audits and inspections, with the ability to present CSV topics to internal auditors and national/international
• regulatory authorities.
• Ability to work independently as well as effectively collaborate across departments.
• Excellent communication skills, decision-making ability, and time management.

What we offer:

• Competitive salary
• Private medical care
• Life insurance
• Employee Pension Plan (PPE)
• An extra vacation day
• and more..