Senior Associate, Quality Compliance Specialist

1 week 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 the pharmaceutical industry.

Key Responsibilities
  • Conduct batch certification reviews of site QA activities related to manufacturing batch records, packaging records, QC lab records, certificates of analysis/compliance, and supporting documentation.
  • Support batch certification activities related to USA commercial distribution.
  • Conduct investigation reviews of site deviations, including planned, unplanned deviations, OOS/OOT investigations, and ensure conclusions and corrective actions are adequate.
  • 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.
  • 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 7 years of experience within the pharmaceutical industry.
  • Experience working in an international multicultural matrix organization.
  • Thorough understanding of GMPs, specifically those relating to good documentation practices.
  • Ability to work effectively in an international multicultural matrix organization.
  • Expertise in software applications, including MS Word, MS Excel, MS Office, Windows, PowerPoint, Microsoft Outlook, Acrobat Reader, TrackWise, and LMS (Learning Management System).
  • Knowledge of project management principles, practices, techniques, and tools.
  • Strong communication, interpersonal, and organizational skills.
  • Intermediate-B1+ level of English language proficiency.
What We Offer

As a Senior Associate, Quality Compliance, you will have the opportunity to work in a dynamic and fast-paced environment with a global pharmaceutical company. You will be part of a team that is dedicated to ensuring the highest quality standards in the industry. We offer a competitive salary, benefits package, and opportunities for professional growth and development.

Please note that the compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time.

This job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job.

Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of the incumbent(s).

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