Validation & QA Analyst

Syneos Health Commercial Solutions; Hyderabad; On-site; INR 700,000 - 1,100,000; Full time

Job summary

Syneos Health Commercial Solutions in Hyderabad is seeking a Quality Analyst to develop testing documents and execute test scripts for projects using quality guidelines, with additional support to Deployment Solutions’ QMS.

The role requires a BA/BS in computer science and 3+ years in formal computer system validations within regulated pharma/medical devices, including PDMA and 21 CFR Part 11. CRM testing experience is a plus.

Qualifications

• BA/BS preferably in computer science or equivalent.
• 3+ years’ experience in formal computer system validations in a regulated industry.
• 3+ years’ experience supporting the pharmaceutical and/or medical device industry.
• 3+ years’ experience performing validation/testing to PDMA and 21 CFR Part 11.

Responsibilities

• Plan and execute System Validations of client configurations and/or vendor software services with regulatory implications.
• Provide validation time/resource estimations and prepare Validation Plans.
• Prepare and deliver appropriate Protocols (OQ, PQ) and Traceability Matrices; execute protocols and document testing evidence.
• Document deviations/non-conformances and prepare Validation Summary Reports.
• CRM QA Testing: plan and execute QA testing of client CRM deliverables; prepare Test Plans and datasets; coordinate data files with third parties and execute scripts.
• Support Deployment Solutions QMS: documentation management for SOPs, Work Instructions, Policies, and Standards.

Skills

cGDP adherence

Multi-tasking

Communication skills

Detail orientation

Problem solving

Planning

Microsoft Office

Requirements translation

Education

BA/BS in Computer Science or equivalent

Job description

Description

We are looking for an innovative and experienced Quality Analyst to join our team. The QA Analyst is responsible for developing all testing related documents and execute the test scripts for the assigned projects using recommended quality guidelines. Also, provide additional support to Deployment Solutions’ QMS as requested.

Description

We are looking for an innovative and experienced Quality Analyst to join our team. The QA Analyst is responsible for developing all testing related documents and execute the test scripts for the assigned projects using recommended quality guidelines. Also, provide additional support to Deployment Solutions’ QMS as requested.

Job Responsibilities

Computer System Validations: plan and execute System Validations of client configurations and/or vendor software services with regulatory (PDMA, 21 CFR Part 11) implications and/or to support the work of third‑party validation consultants on large validation projects.

• As assigned per CRM implementation sampling deployments, and following department SOPs:
• Provide validation time/resource estimations
• Prepare and deliver Validation Plans
• Prepare and deliver appropriate Protocols (Operational Qualification, Performance Qualification)
• Prepare and deliver Traceability Matrices
• Execute protocols; document testing evidence
• Document deviations/non-conformances
• Prepare and deliver Validation Summary Reports

CRM QA Testing: Secondary responsibility involves standard planning and execution of QA testing of client CRM project deliverables (data feeds, basic system functionality as client-configured, etc.).

• As assigned per CRM implementation or other customer engagements, and following department SOPs:
• Provide test time/resource estimations
• Prepare and deliver Test Plans (across all testing requirements)
• Write/modify test scripts/scenarios
• Prepare and deliver test datasets to represent normal Rep activities and functional triggers (shipment files & acknowledgements) as needed
• Coordinate required data files for testing with appropriate third parties via Data Services
• Execute test scripts and/or assist with test script execution and documentation
• Document deviations
• Prepare and deliver Test Summary Report

Support for Deployment Solutions QMS for the following:

• Documentation management understanding for:
• Standard Operating Procedures & Work Instructions
• Policies & Standards
• System Validation packages
• Testing scripts, evidence
• Additional TBD as QMS matures and scope increases

Qualification Requirements

• BA/BS preferably in computer science or equivalent
• 3+ years’ experience in formal computer system validations in a regulated industry
• 3+ years’ experience supporting the pharmaceutical and/or medical device industry
• 3+ years’ experience performing validation/testing to PDMA and 21 CFR Part 11

Preferred

• SFA/CRM background
• Experience with Salesforce or Veeva CRM products
• Testing experience on software applications across multiple platforms
• Quality Management background

Skills

• Adherence to current Good Documentation Practices (cGDP)
• Ability to multi-task, work under deadlines, manage expectations and consistently deliver on time
• Ability to respond quickly to ad hoc requests
• Strong attention to process compliance and detail
• Excellent communication skills both verbal and written
• Detail oriented / analytical skills
• Excellent interpersonal skills
• Planning and personal organizational skillsSkilled in standard Microsoft Office programs (MS Word, MS Excel)
• Adept in troubleshooting and problem solving.
• Ability to translate customer needs (e.g. BRD) into technical requirements (e.g. validation protocols

At Syneos Health, we are dedicated to building a diverse, inclusive and authentic workplace. If your past experience doesn’t align perfectly, we encourage you to apply anyway. At times, we will consider transferable skills from previous roles. We also encourage you to join our Talent Network to stay connected to additional career opportunities.

Why Syneos Health?

We partner with industry experts to solve and execute against today’s toughest commercialization challenges facing the world’s leading healthcare companies. The diversification and breadth of our new and existing partnerships create a multitude of career paths and employment opportunities on our Commercial Operations and Leadership teams. Join our game-changing, global company dedicated to creating better, smarter, faster ways to get biopharmaceutical therapies to patients. Experience the thrill of knowing that your everyday efforts are contributing to improving patients’ lives around the world.

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Syneos Health companies are affirmative action/equal opportunity employers (Minorities/Females/Veterans/Disabled)