Test Consultant

TEST CONSULANT

The QA Test team develops and executes test cases on software solutions to ensure new functionality and fix known defects. Test Consultants design, implement, test and deploy business intelligence solutions to meet business process requirements.

Responsibilities:

• Partner with key business stakeholders to develop policies and procedures necessary to lead/guide the implementation and maintenance of a compliant, efficient, and integrated CSV program.
• Draft, review and approve validation deliverables such as user requirements, technical design specifications, IQ/OQ/PQ scripts and reports, error logs, configuration document, traceability matrix and document 21 CFR Part 11 and EU Annex 11 compliance.
• Perform gap analysis and implement SOP harmonization by aligning customer Quality Management System to ITIL and GAMP 5 guidelines.
• Create POVs on CSA and Validation strategy for AI/ML models, R and Python packages validation and implement the solution in client environment.
• Understand the various testing activities: Unit, System, Component, User Acceptance, Performance, Integration and Regression.
• Manage end to end testing / validation lifecycle on applications likes - Solution Manager, JIRA, and HP ALM (desired).
• Provide SME support on topics relevant to GxP, CSV, 21 CFR Part 11, Annex 11 etc.
• Maintain and implement quality systems to ensure compliance with applicable global regulatory requirements.
• Develop CSV Standard Operating Procedures (SOPs) as required.

Qualifications:

• Bachelors/Master s degree in engineering, Science, Medical or related field.
• Hands-on experience in Computer System Validation of Applications and Infrastructure Qualification.
• A minimum of 8-11 years of experience in computer systems validation and hands on experience within GxP (GCP/GMP regulated environment (FDA, EU, MHRA)).
• Strong working knowledge and experience of global regulations and guidelines such as GAMP, CFR Part 11 Annex 11 and other FDA regulations i.e. 21 CFR Part 210, 211, Part 820, ICH Q9, QSRs, ISO 13485, HIPPA etc. coupled with ability to practically apply such knowledge.
• Strong knowledge of industry standards like GAMP5, FDA 21 CFR Part 11 on electronic records, electronic signatures etc.
• Proven experience developing full validation documentation and testing protocols (IQ/OQ/PQ/UAT) within the various SDLC or Agile phases.
• Good understanding of automation scripts and the designing/configuring the test automation frameworks.
• Experience with end-to-end testing of the ETL process of a data warehouse system.
• SQL skills for development of expected results and troubleshooting problems found during testing.
• Experiences working with Pharma/Biotech implementation of RD systems.
• Define risk-based strategies for validation of computerized systems utilizing AI/ML models in alignment with GAMP5.
• Perform system risk assessments - GxP, Business, and Functional Risk Assessment, systems gap analysis, review and approve action plans to ensure compliance during and after the system validation.
• Understanding, preparing, and implementing CSV and project related SOP s and WI s. Well versed in Good Documentation Practices.
• Validation life cycle in Agile and other SDLC methodology.
• A thorough understanding of drug development processes from discovery through development and post-marketing, with an ability to understand business requirements and translate them into practical solutions.
• Provide training related to computerized systems validation, quality and compliance to users and appropriate personnel.

Perks Benefits:

ZS offers a comprehensive total rewards package including health and well-being, financial planning, annual leave, personal growth and professional development. Our robust skills development programs, multiple career progression options and internal mobility paths and collaborative culture empowers you to thrive as an individual and global team member.

We are committed to giving our employees a flexible and connected way of working. A flexible and connected ZS allows us to combine work from home and on-site presence at clients/ZS offices for the majority of our week. The magic of ZS culture and innovation thrives in both planned and spontaneous face-to-face connections.

Considering applying

At ZS, were building a diverse and inclusive company where people bring their passions to inspire life-changing impact in global healthcare and beyond. We are most interested in finding the best candidate for the job and recognize the value that candidates with all backgrounds, including non-traditional ones, bring. If you are interested in joining us, we encourage you to apply even if you dont meet 100% of the requirements listed above.

ZS is an equal opportunity employer and is committed to providing equal employment and advancement opportunities without regard to any class protected by applicable law.

To Complete Your Application:

Candidates must possess work authorization for their intended country of employment. An on-line application, including a full set of transcripts (official or unofficial), is required to be considered.