QA Computerized Systems Senior Specialist (female/male) (Duchnice)

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 responsibilities

• Defining, planning, and reportting CSV activities in line with regulatory expectations.
• Reviewing and approving validation documentation (e.g. URS, risk assessments, test protocols).
• Supporting CSV efforts across key areas: Production Systems, Laboratory Systems, and Enterprise Systems.
• Monitoring validation project progress and escalating risks to ensure smooth implementation.
• Collaborating with system users, subject matter experts, and software vendors to implement validated solutions.
• Assessing and defining the appropriate level of validation required following system changes.
• Identifying systems requiring validation using a risk-based approach.
• Representing the QA CSV function during internal and external audits.
• Training site personnel on CSV requirements and data integrity principles.
• Initiating and reviewing 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.

We offer

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

At Rezon Bio, we believe in diversity and equality. Our recruitment process is conducted in a fully transparent manner and with respect for non-discrimination principles – regardless of gender, age, orientation, gender identity, or other individual characteristics. We encourage all individuals who meet the requirements to apply, including women, men, and non-binary persons. What matters most to us is your experience, skills, and passion for achieving goals together!