Senior Quality Assurance Compliance Specialist

at  Piramal Enterprises

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.
  In the three decades of its existence, Piramal Group has pursued a twin strategy of both organic and inorganic growth.
  Driven by its core values, Piramal Group steadfastly pursues inclusive growth, while adhering to ethical and values-driven practices.

Key Competencies (knowledge, skills, and abilities every person must possess to be successful)

• 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

• Responsible for the review, approval, and disposition of finished product for the site and final CoA signature.
• Facilitates client project management as required ensuring “quality on time and in full”.
• Coordinates the investigation and closure of non-conformances ensuring appropriate corrective and preventive actions (CAPA) and change controls are initiated and deviations are closed.
• Leads or participates in focused deviation cross-functional investigations, improvement projects.
• Reviews and approves laboratory investigations in a timely manner and ensures appropriate root cause is identified.
• Provides assistance to other QA associates and assist with department training.
• Provides support to QA management during regulatory audits.
• Reviews BOMs, inspection plans, pallet patterns, calibration records and SOPs.
• Performs internal audits and assist in writing reports for audits.
• Maintains and revises procedures related to the quality assurance activities. Supports 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.
• Performs 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.
• Performs special projects and/or assignments as indicated by Quality Management.Responsible for maintenance and revision procedures related to document control.

Key Competencies (knowledge, skills, and abilities every person must possess to be successful)

• 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.