Associate QA

2 - 6 years

0 Lacs

Posted:2 days ago| Platform: Shine logo

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Work Mode

On-site

Job Type

Full Time

Job Description

As an Associate QA at Syneos Health, you will be part of a leading fully integrated biopharmaceutical solutions organization focused on accelerating customer success. You will play a crucial role in supporting the auditing team by gathering documentation for audits and inspections and tracking the schedule of audits and inspections in the enterprise quality management system. Key Responsibilities: - Support the implementation of PSEA awareness activities and ensure completion of mandatory training for relevant groups. - Collaborate with cross-functional teams to develop, implement, and enhance processes, controls, and tools. - Monitor actionable metrics and KPIs, initiate remediation actions as needed, and escalate concerns to the Medical Operations Manager. - Prepare reports and trend analyses at defined intervals to track compliance metrics for Patient Programs and related initiatives. - Coordinate review meetings with internal stakeholders for Patient Programs and other related activities. - Enforce medical compliance in alignment with global policies, ensuring adherence to the highest ethical standards. - Act as a backup for operational implementation of Events & Scientific External Experts (SEE) engagement approval process. - Contribute to projects aimed at simplifying and optimizing medical processes, performance, or governance. - Assist in tracking planned and scheduled audits in the Enterprise Quality Management System (EQMS) and maintain QA documentation archives. Qualifications: - Minimum 2 years of experience in Medical Affairs or a related field with a solid understanding of the current pharmaceutical environment. - Proficiency in Microsoft Office programs including Word, Excel, PowerPoint, and Outlook. - Strong multitasking and prioritization skills. - Relevant experience in project management is highly desirable. - Ability to work cross-functionally, with an agile mindset, and as a strong team player. Syneos Health is committed to developing its people through career progression, supportive management, training programs, and a total rewards program. The company values diversity of thoughts, backgrounds, and perspectives to create an inclusive work environment where everyone feels they belong. Please note that tasks, duties, and responsibilities may vary at the discretion of the Company, and equivalent experience, skills, and education will also be considered. The Company is dedicated to compliance with relevant legislation and providing reasonable accommodations as needed.,

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Syneos Health logo
Syneos Health

Biotechnology Research

Morrisville NC

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