Senior Associate, Quality Compliance Specialist

2 weeks ago

Princeton, New Jersey, United States Sun Pharmaceutical Industries, Inc. Full time
Job Summary

We are seeking a highly skilled Senior Associate, Quality Compliance to join our team at Sun Pharmaceutical Industries, Inc. This role will be responsible for ensuring compliance with regulatory requirements and good manufacturing practices (GMPs) in our manufacturing and quality assurance processes.

Key Responsibilities
  • Support batch certification activities related to commercial distribution in the USA.
  • Conduct investigation reviews of site deviations, including planned and unplanned deviations, OOS/OOT investigations, and ensure adequate conclusions and corrective actions.
  • Review cleaning validation-related documents, including plans, protocols, reports, and projects.
  • Support quality risk analysis related to manufacturing processes and equipment cleaning, including FMEA.
  • Review periodic reports related to cleaning lifecycle, including Continued Process Verification (CPV) and Annual Cleaning Review.
  • Ensure compliance with regulatory requirements on product, process, equipment, and release procedures.
  • Assist in ensuring FDA readiness plan for the facility and provide support for all regulatory audits, internal/external inspections, and other audits.
  • Participate in and conduct mock inspections to prepare the facility for audits and assess gaps in the system; review documents for compliance with current regulations and cGMPs.
  • Identify compliance issues and support the implementation of changes for constant improvements.
  • Support adherence to SOPs and policies and assist in ensuring that procedures reflect current practice.
Requirements
  • Minimum of seven (7) years of experience within the pharmaceutical industry.
  • Experience working in an international multicultural matrix organization.
  • Strong communication, interpersonal, and organizational skills.
  • Expertise in software applications, including MS Word, MS Excel, MS Office, Windows, PowerPoint, Microsoft Outlook, Acrobat Reader, TrackWise, and LMS.
  • Knowledge of project management principles, practices, techniques, and tools.
  • Thorough understanding of GMPs, specifically those relating to good documentation practices.
  • Ability to work effectively in an international multicultural matrix organization.
  • English language proficiency at an Intermediate-B1+ level (comparable to Global CEFR Independent B1).
Work Environment

This role will be based in a corporate office environment with occasional travel to manufacturing and laboratory settings.

Compensation and Benefits

Actual base compensation may vary based on geographical location and experience. This position is part of the Annual Performance Bonus Plan and may be eligible for employee benefit programs, including medical, dental, and vision coverage, life insurance, disability insurance, 401(k) savings plan, flexible spending accounts, and the employee assistance program.

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