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Bethlehem, Pennsylvania, United States
Onsite
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Division
Piramal Critical CarePiramal Critical Care (PCC), a business unit of Piramal Pharma, is the fourth-largest producer of inhaled anesthetics and a global player in hospital generics. We are motivated by our vision of commitment to delivering critical care solutions for patients and healthcare providers across the globe while achieving sustainable and profitable growth for all the stakeholders.
PCC maintains a wide presence across the US, Europe, and more than 100 countries across the globe. Its rich product portfolio includes Inhalation Anesthetics such as Sevoflurane, Isoflurane and Halothane as well as Intrathecal Baclofen therapy, for spasticity management.
PCC has a strong manufacturing and process development experience with wholly-owned, state-of-the-art manufacturing facilities in the United States and India, inspected periodically by the US FDA and the UK MHRA and other regulators. The strategic locations of our facilities help us supply high-quality products around the world, timely at optimal costs.
For more details, please visit https://www.piramalcriticalcare.com/global/
Job Title
Senior Quality Assurance Compliance SpecialistJob Description
Provides continuous oversight of daily Quality activities to ensure compliance with internal procedures and regulatory requirements. Responsible for documentation control, review, and management to maintain GMP and regulatory compliance.Essential Duties and Responsibilities
Review, approve, and disposition finished products and provide final Certificate of Analysis (CoA) approval
Facilitate client project management to ensure quality deliverables are completed on time and in full
Coordinate investigation and closure of non-conformances, ensuring CAPA and change controls are initiated and completed
Lead or participate in cross-functional deviation investigations and improvement projects
Review and approve laboratory investigations, ensuring root cause identification
Support QA team members and assist in departmental training
Provide support during regulatory audits
Review BOMs, inspection plans, pallet patterns, calibration records, and SOPs
Perform internal audits and assist in audit report preparation
Maintain and revise QA procedures
Support Annual Product Review (APR) through data collection and database management
Manage vendor complaint processes
Monitor and trend deviations, laboratory investigations (LIs), CAPAs, customer complaints, and change controls
Perform special projects as assigned by Quality Management
Oversee and review obsolete material destruction processes
Conduct quality inspections on packaging lines as required
Maintain supplier approval programs
Support and maintain site Document Control System
Review, approve, and close Document Change Requests
Track document changes using DCC tools and ensure closure of associated actions
Maintain document archives, including offsite storage
Print and issue controlled documents, forms, and logbooks
Review documentation in eDMS for formatting and accuracy
Upload and manage documents in the electronic Document Management System (eDMS)
Route documents for approval within eDMS workflows
Retrieve documentation for audits in a timely manner
Maintain and revise document control procedures
Key Competencies (knowledge, skills, and abilities every person must possess to be successful)
Strong critical thinking and problem-solving skills
Excellent customer service and professional communication skills
Strong verbal and written communication abilities
Energetic, motivated, and detail-oriented approach
Strong organizational skills with attention to detail
Ability to analyze data, identify trends, and make regulatory decisions
Ability to explain issues, propose solutions, and manage urgent requests effectively
Capability to drive projects and implement process/system improvements
Education/Experience
Bachelor’s degree in a scientific, quality assurance, or technical field
Minimum 5+ years of relevant experience
Strong understanding of pharmaceutical cGMP, industry standards, and regulations
Strong cross-functional communication skills across different levels of the organization
Expertise in Quality systems and tools
Proficiency in Microsoft Outlook, Excel, Word, and other web-based systems
Strong understanding of computer system validation and GAMP requirements