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Senior Quality Assurance Compliance Specialist

2 meses atrás

Belém, Pará, Brasil Piramal Pharma Solutions Tempo inteiro
Job Overview

Piramal Pharma Solutions is seeking a highly skilled Senior Quality Assurance Compliance Specialist to join our team. As a key member of our Quality Assurance department, you will be responsible for ensuring compliance with internal procedures and regulatory requirements.

Key Responsibilities
  • Provide continuous oversight of all daily Quality activities to ensure compliance with internal procedures and regulatory requirements.
  • Review, approve, and disposition of finished product for the site and final CoA signature.
  • Facilitate client project management as required, ensuring "quality on time and in full".
  • Coordinate the investigation and closure of non-conformances, ensuring appropriate corrective and preventive actions (CAPA) and change controls are initiated and deviations are closed.
  • Lead or participate in focused deviation cross-functional investigations, improvement projects.
  • Review and approve laboratory investigations in a timely manner and ensure appropriate root cause is identified.
  • Provide assistance to other QA associates and assist with department training.
  • Provide support to QA management during regulatory audits.
  • Review BOMs, inspection plans, pallet patterns, calibration records, and SOPs.
  • Perform internal audits and assist in writing reports for audits.
  • Maintain and revise procedures related to the quality assurance activities. Support Annual Product Review (APR) reports by collecting batch record data, creating and maintaining databases.
  • Maintain the vendor complaint process.
  • Maintain, monitor, and provide trend analysis of Dis, Lis, CAPAs, customer complaints, and change controls.
  • Perform special projects and/or assignments as indicated by Quality Management.
  • Oversee and review of Obsolete material destruction.
  • Perform Quality inspections on packaging line as needed.
  • Maintain supplier approval program.
  • Support/Maintain site Document Control System.
    • Review, approve, and close out Document change Requests.
    • Tracking of changes using DCC spreadsheet and supporting actions through closure.
    • Maintain original documentation archive and archival of documents offsite.
    • Printing of new and revised documents, Issuance of forms, logbooks.
    • Review documentation submitted for routing in eDMS for proper formatting and accuracy.
    • Load documents into an electronic Documentation Management System (eDMS).
    • Route documents for approval in the eDMS.
    • Recall documentation for audits in a timely manner.
  • Responsible for maintenance and revision procedures related to document control.
Key Competencies
  • Critical Thinking — using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions, or approaches to problems.
  • Excellent customer service skills and professional demeanor at all times to interface effectively with all internal and external customers.
  • Excellent verbal and written communication skills.
  • Energetic, enthusiastic, and motivated disposition.
  • Attention to detail with strong organizational skills.
  • Ability to explain problems, solutions, and make recommendations, and the ability to manage various urgent requests in a professional manner.
  • Ability to analyze data/trends to make sound regulatory interpretation while preparing metrics and reports.
  • The ability to drive projects in relation to implementation of new workflows and updates to new systems.
Education / Experience
  • Bachelor's degree in relevant scientific quality assurance / technical field.
  • 5+ years of experience.
  • Strong understanding of pharmaceutical cGMP, industry standards, and regulations.
  • Strong verbal and written communication skills with the ability to interact across functions, departments, and seniority levels.
  • Expert level user for Quality computer systems.
  • Knowledge of and ability to use Microsoft Outlook, Excel, and Word, as well as other web-based systems.
  • Thorough understanding of computer system validation and GAMP requirements.