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Validation & QA Analyst
hace 2 semanas
**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 executing test scripts for assigned projects using recommended quality guidelines. The role also provides additional support to Deployment Solutions’ QMS as requested.
**Responsibilities**:
**Computer System Validations**
- Plan and execute system validations of client configurations and/or vendor software services with regulatory implications (PDMA, 21 CFR Part 11).
- Provide validation time/resource estimations.
- Prepare and deliver Validation Plans, Protocols (OQ, PQ), and Traceability Matrices.
- Execute protocols and document testing evidence.
- Document deviations/non-conformances.
- Prepare and deliver Validation Summary Reports.
**CRM QA Testing**
- Provide test time/resource estimations.
- Prepare and deliver Test Plans covering all requirements.
- Write/modify test scripts and scenarios.
- Prepare and deliver test datasets to represent Rep activities and functional triggers.
- Coordinate required data files for testing with third parties via Data Services.
- Execute test scripts and assist with execution and documentation.
- Document deviations and prepare Test Summary Reports.
**Deployment Solutions QMS Support**
- Assist in documentation management, including SOPs, Work Instructions, Policies, Standards, validation packages, and testing scripts/evidence.
- Support additional QMS activities as scope increases.
**Qualification Requirements**
**Required**
- BA/BS in Computer Science or equivalent.
- 3+ years of computer system validations in a regulated industry.
- 3+ years supporting the pharmaceutical and/or medical device industry.
- 3+ years performing validation/testing to PDMA and 21 CFR Part 11.
**Preferred**
- SFA/CRM background.
- Experience with Salesforce or Veeva CRM.
- Testing across multiple platforms.
- Quality Management background.
**Skills**
- Adherence to current Good Documentation Practices (cGDP).
- Strong multi-tasking, time management, and organizational skills.
- Excellent written and verbal communication.
- Analytical and detail-oriented.
- Strong interpersonal skills and ability to work under pressure.
- Proficient in Microsoft Office (Word, Excel).
- Troubleshooting and problem-solving skills.
- Ability to translate business needs into technical requirements.
**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.
Work Here Matters Everywhere | How are you inspired to change lives?
- Syneos Health companies are affirmative action/equal opportunity employers (Minorities/Females/Veterans/Disabled)_
