5-7 years of experience in validation, IT quality assurance, quality control, or related fields.
Hands-on expertise in validating computerized systems.
In-depth knowledge of pharmaceutical regulatory compliance for US and EU/MHRA.
Ability to thrive in a dynamic, cross-functional team setting.
Demonstrated skill in data governance and visualization techniques.
Preferred familiarity with analytical tools like UPLC, HPLC, qPCR, and Excel validation.
Bachelor's degree in Computer Science, Engineering, or Biological Sciences.
Responsibilities
Apply quality and cGMP standards to validate computer systems.
Ensure compliance with Data Integrity principles during validations.
Facilitate risk assessments to identify project requirements.
Collaborate with teams to enhance processes, including change management and configuration.
Develop and document validation materials such as protocols and SOPs.
Analyze validation data and troubleshoot with technical teams.
Communicate with stakeholders about validation progress and system needs.
Benefits
Collaborative cross-functional work environment.
Opportunities to enhance process optimization skills.
Exposure to state-of-the-art validation practices and tools.
Engagement with stakeholders across multiple levels of the organization.
Professional development in regulatory compliance and data integrity standards.
Full Job Description
Job Description:
In this role, you will collaborate with cross-functional teams to ensure systems meet quality standards and regulatory requirements through a risk-based approach. This position focuses on maintaining data integrity and system lifecycle management while contributing to operational efficiency.
Responsibilities:
pply quality standards and cGMP requirements to validate computer systems, including hardware, software, procedures, and training.
Ensure system validation aligns with Data Integrity principles (ALCOA) and includes appropriate testing strategies.
Facilitate risk assessments to identify validation deliverables and project requirements.
Collaborate with Quality Assurance and other teams to optimize processes such as change management, backup policies, configuration management, and periodic reviews.
Develop and execute validation documentation, including requirements, user acceptance testing, SOPs, system impact assessments, traceability matrices, protocols, and reports.
nalyze validation data and troubleshoot issues in collaboration with technical teams.
Maintain communication with stakeholders to address system needs, validation progress, and related concerns.
Requirements:
Experience in validation, IT quality assurance, quality control, biomanufacturing, clinical, or regulatory operations.
Hands-on experience in validating computerized systems.
Strong understanding of pharmaceutical industry regulatory compliance, particularly US and EU/MHRA data integrity guidance.
bility to work effectively in a dynamic, cross-functional team environment.
Proven expertise in applying data governance measures and creating impactful data visualizations.
Preferred experience with tools and systems such as UPLC, HPLC, HIAC, qPCR, NanoDrop, TOC Analyzer, Osmometer, Cell Counters, and Excel spreadsheet validation.
Bachelor's degree in Computer Science, Engineering, Biological Sciences, or a related field.
