Validation & QA Analyst

Syneos Health; Hyderabad; On-site; INR 800,000 - 1,200,000; Full time

Job summary

Syneos Health in Hyderabad, India seeks a Quality Analyst to lead validation and QA testing for CRM and deployment solutions. You will develop validation documents, execute test scripts, and support QMS processes in a regulated environment. Strong planning, documentation, and cross-functional collaboration are essential.

The role emphasizes computer system validations, CRM QA testing, and adherence to PDMA/21 CFR Part 11, with opportunities to contribute to QMS improvements as scope expands.

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 Computer System Validations with regulatory implications.
• Prepare and deliver Validation Plans, Protocols, Traceability Matrices, and Validation Summary Reports.
• Execute validation testing of CRM projects and client data feeds; document deviations.

Skills

GDP (cGDP)

Multi-tasking

Communication

Detail oriented

Interpersonal skills

Planning

MS Office

Education

BA/BS in CS or equivalent

Tools

Salesforce

Veeva CRM

MS Office

Job description

Updated: Yesterday

Location: Hyderabad, India

Job ID: 17600

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

Required

1. 1. BA/BS preferably in computer science or equivalent
2. 2. 3+ years’ experience in formal computer system validations in a regulated industry
3. 3. 3+ years’ experience supporting the pharmaceutical and/or medical device industry
4. 4. 3+ years’ experience performing validation/testing to PDMA and 21 CFR Part 11

Preferred

1. 1. SFA/CRM background
2. 2. Experience with Salesforce or Veeva CRM products
3. 3. Testing experience on software applications across multiple platforms
4. 4. 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 skills
• Skilled 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

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

Discover what our more than 25,000 employees already know: work here matterseverywhere. We work hard,and smart, all in the name of getting much-needed therapies to thosewho need them most. A career with Syneos Health means your everyday workimprovespatients’ lives around the world. Selecting us as an employer secures acareer inwhich you’re guaranteed to:

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization builtto accelerate customer success. We translate unique clinical, medical affairs and commercialinsights into outcomes to address modern market realities. To learn more visit syneoshealth.com .

Syneos Health is an Equal Opportunity Employer. All qualified applicants will receiveconsideration for employment without regard to race, color, age, religion, marital status,ethnicity, national origin, sex, gender, gender identity, sexual orientation, protectedveteran status, disability or any other legally protected status and will not bediscriminated against. If you are an individual with a disability who requires reasonableaccommodation to complete any part of our application process, including the use of thiswebsite, please contact us at: Email: [emailprotected] One of our staff members willwork with you to provide alternate means to submit your application.