Assess the validation impact of system changes and coordinate updates to affected deliverables
Prepare and review validation test cases and support controlled validation test execution
Support investigations of validation deviations and track related CAPA actions
Perform scheduled periodic reviews of validated systems
Collaborate with cross-functional teams to ensure compliant product development
Maintain audit readiness and provide evidence for audit scoping and planning
Proactively identify risks, evaluate audit and inspection findings, monitor remediation and action plans
Support Quality Assurance Agreements with suppliers.
Train teams on compliance and documentation standards.
Working Relations
Team members and Team Leader
System Owners, Process Managers, internal clients and cross-functional IT and non-IT teams, external IT Service Providers
Internal and external auditors
Qualifications
Soft Skills
Passion for quality, compliance, and technology
Attention to detail and focus on accuracy and completeness
Strong communication and collaboration skills
Ability to work across cultures and global teams
Strong organizational skills and ability to manage multiple tasks
Willingness to learn and develop skills
Ability to train and share knowledge with others
Hard Skills
University degree in IT, natural sciences, or related field
Approx 5 years of experience in computerized system validation (CSV) or IT Quality assurance for regulated industries
Knowledge of GxP environment, preferably in the GCP area, and risk-based validation practices
English proficiency at B2/C1 level
Advanced Microsoft Office skills (Excel, Word, PowerPoint)
Experience with software development, agile environment and digital collaboration tools (Teams, SharePoint, Jira, AzureDevOps)
Basic knowledge of document management and validation lifecycle systems
Familiarity with audit, risk, change, or deviation management (beneficial)
Exposure to Veeva Vault products, Clinical Data management systems, or cloud-based integration and data platforms is an advantage
YOUR APPLICATION
This position may be allocated across multiple countries (India & Gdańsk), and elements of the recruitment process may vary to ensure compliance with local employment laws. At Bayer, we are committed to transparency and equal pay for equal work or work of equal value. Due to differences in currencies and local compensation structures, detailed salary information will be shared with candidates during the recruitment process once they are identified as potential prospects. Final compensation is determined based on objective factors such as experience, qualifications, scope of responsibility. This position is eligible for variable pay components, such as performance‑based bonuses, awarded in accordance with the applicable employee group, role scope, and compensation structure.Benefits may vary depending on role and employment conditions.
Bayer is an equal opportunity employer that strongly values fairness and respect at work. We welcome applications from all individuals, regardless of race, religion, gender, age, physical characteristics, disability, sexual orientation etc. We are committed to treating all applicants fairly and avoiding discrimination.
Location
India : Karnataka : Bangalore || Poland : Pomorskie : Gdańsk
Division
Enabling Functions
Reference Code
896276
Contact Us
+ 022-25311234
