Syneos Health Hiring QA Auditor

Zydus Cadila Ltd; Pune District; On-site; INR 600,000 - 900,000; Full time

Job summary

Syneos Health seeks an Auditor II, QA with Good Pharmacovigilance Practice experience for audits that assess GxP compliance and guide regulatory inspections. The role involves planning, reporting, and coordinating responses to findings while ensuring timely closure of audits.

The candidate should have a Bachelor’s degree in science/healthcare and solid knowledge of regulatory requirements, with strong communication and documentation skills.

Qualifications

• Bachelor’s degree in science/healthcare or equivalent with GxP QA auditing knowledge.
• Good knowledge of GxP regulatory requirements and audit terminology.
• Strong written and verbal communication with ability to draft concise reports.

Responsibilities

• Plans and conducts assigned audits and hosts/assists customer audits.
• Writes and issues audit reports, communicates findings clearly.
• Reviews audit findings responses for accuracy and completeness.
• Closes assigned audits and supports regulatory inspections as needed.
• Travel up to 50% may be required.

Skills

Audit planning

Audit reporting

Regulatory know-how

Interpersonal skills

Communication

Documentation

Education

Bachelor's degree in science/healthcare

Tools

MS Office

SharePoint

Job description

Syneos Health is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress. Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.***Post :*** Auditor II, QA (Good Pharmacovigilance Practice exp required)***JOB SUMMARY*** Conduct audits to assess compliance with applicable regulations, company policies, standard operating procedures (SOPs) and work instructions (WIs), contracts and project-specific requirements. Hosts and supports customer audits and regulatory inspections in accordance with QA SOPs and WIs.***JOB RESPONSIBILITIES*** General Profile Syneos Health Audits • Plans and conducts assigned audits. • Writes and issues audit reports, ensuring clear communication of audit findings to the auditees and relevant management. • Reviews responses to audit findings for appropriateness and completeness. • Closes assigned audits. Customer Audits/Inspections • Prepares for and hosts or supports customer audits.Assists senior QA personnel in hosting or supporting Regulatory Authority Inspections. undefined Supervision • Requires some instructions on day-to-day work and new assignments.undefined Other tasks • Performs other work-related duties as assigned.Moderate travel may be required (up to 50%).***Candidate Profile*** • Requires a Bachelor’s degree in the science/health care field or equivalent with moderate experience in GxP quality assurance auditing.Good knowledge of GxP regulatory requirements. • Knowledge of Medical and technical terminology related to the audit types to be conducted.Computer literacy commensurate with job requirements (Microsoft Office suite; basic Sharepoint proficiency). • Able to handle multiple tasks to meet timelines in a dynamic environment.Strong organizational, presentation and interpersonal skills. • Cultural sensitivity to allow effective communication with stakeholders from diverse cultural backgrounds. • Ability to negotiate and provide constructive feedback. • Well-developed communication skills and the ability to write concise, accurate reports and other necessary documentation.***Additional Information*** ***Experience :*** Good Pharmacovigilance Practice exp required **Qualification :** Bachelor’s degree in the science/health **Location :** Hyderabad, Gurugram, Pune **Industry Type :** Pharma/ Healthcare/ Clinical research **End Date :** October 31, 2026> ***QA Auditor :*** ***Apply Online***Post Views: 10**Job Category:** Pharma**Job Type:** Full Time**Job Location:** Hyderabad Gurugram