Compliance Associate

GxP Compliance Associate

Here at Syndigo, we're enabling our clients to deliver better eCommerce experiences. We've mastered the right data, right now. From creation to sale, that's the value our partners get from us - a holistic, truly differentiated end-to-end solution that closes the loop while increasing sales.

Basically, we're the accurate data behind how people feel when they shop online with confidence!

We cannot do all of this without our amazing people! Our employees make the magic happen here at Syndigo and we're growing rapidly! We're ready for you to collaborate with us to challenge the status quo!

We are seeking a highly motivated GxP Compliance Associate to join our team. The GxP Compliance Associate will support the quality assurance team by collecting audit evidence, performing spot checks, and conducting audits of systems to ensure compliance with GxP standards. This entry-level role will involve maintaining thorough documentation and assisting in the implementation of corrective actions to address identified non-compliances. The ideal candidate will be detail-oriented, organized, and eager to contribute to the continuous improvement of our compliance processes. The Audit Analyst will work closely with cross-functional teams, including Sales, Marketing, Product, Infosec, Legal, and others to help define deliverables and maintain records of compliance. Further the Audit Analyst will work with the information security team in performing cross functional reviews of systems within the IT/IS systems.

Responsibilities:

• Audit Evidence Collection
  • Gather, organize, and manage documentation and records required for GxP audits.
  • Ensure all audit evidence is accurate, complete, and readily accessible for review.
• Spot Checks and System Audits
  • Perform regular spot checks on various systems and processes to ensure ongoing compliance with GxP standards.
  • Conduct routine audits of in-scope systems.
  • Assist with Information security system/software audits where necessary
• Documentation Maintenance
  • Maintain up-to-date and accurate documentation of all audit activities and findings.
  • Ensure proper filing and storage of all records in compliance with regulatory requirements.
• Corrective Actions
  • Assist in identifying non-compliances and discrepancies during audits.
  • Collaborate with relevant departments to develop and implement corrective and preventive actions (CAPAs).
  • Track the progress of CAPAs to ensure timely resolution and closure.
• Communication and Reporting
  • Prepare detailed audit reports summarizing findings, observations, and recommendations.
  • Communicate audit results and compliance status to the GxP Audit Manager and other relevant stakeholders.
• Continuous Improvement
  • Participate in training programs to stay current with GxP regulations and best practices.
  • Suggest improvements to audit processes and compliance procedures.

Requirements:

• Work experience: min. 2 years within an auditing role.
• Prior experience in a regulated environment, such as pharmaceuticals, biotechnology, or medical devices, is preferred but not required.
• Languages: fluent in English, both written and oral.
• Advanced command of MS Excel, Teams, PowerPoint, SharePoint and Word.

Skills:

• Ability to work independently and as part of a team.
• Basic understanding of GxP regulations and/or quality assurance principles.

Offer:

• Remote work (Must be based out of India)
• You will be offered an attractive remuneration package and challenging career opportunities.

If you are interested, please submit your CV in English.

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