Pharma Validation Software Engineer/Lead in CyberCraft

Pharma Validation Software Engineer/Lead

Львів, віддалено

We are looking for a person with a 5-6 years of experience in Pharma industries who
will be able to combine management and software engineering roles in our dynamic team.

Requirements:

— Experience in validation processes, including process validation and regulatory
compliance specifically related to validation.
— Knowledge of validation protocols, risk management and industry standards.
— Experience and strong understanding of the healthcare domain.
— Upper Intermediate English.

Responsibilities:

— Review and approve validation deliverables for GxP-regulated computerized
systems to ensure compliance with regulatory requirements and company policies;
— Support internal and external Health Authority regulatory audits;
— Provide CSV guidance and support to project and business teams, resolving
validation documentation corrections and test defects;
— Review and approve validation test scripts, compliance plans, user requirements,
system tests, traceability matrices, and compliance reports;
— Ensure inspection readiness for systems in the CSV portfolio, minimizing risk of
inspection observations;
— Lead and mentor a team through the system lifecycle, utilizing expert knowledge
in risk management;
— Define internal standards for positive risk management using best practices;
— Own, revise, and maintain CSV SOPs;
— Maintain knowledge of company policies, 21 CFR Part 11, Data Integrity, ICH, Q7A, and GAMP principles;
— Assist in preparing and maintaining Quality System documentation and SOPs for
computer system validation.

We offer

— Flexible working hours
— Fair salary (regular performance-based salary reviews)
— 20 working days paid vacation and 15 sick leaves
— Fully paid medical insurance
— English classes in the office
— Bookkeeping and accounting on us
— Cozy, equipped rooms — no open-space
— No time trackers — ability to do quality work
— Approachable management, open to suggestions and innovations
— Friendly team and enjoyable working environment

Project description and details are under NDA.