Senior Compliance Specialist

Be the First to ApplyDivisionPiramal 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 TitleSenior Quality Assurance Compliance SpecialistJob DescriptionProvides 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 ResponsibilitiesReview, approve, and disposition finished products and provide final Certificate of Analysis (CoA) approvalFacilitate client project management to ensure quality deliverables are completed on time and in fullCoordinate investigation and closure of non-conformances, ensuring CAPA and change controls are initiated and completedLead or participate in cross-functional deviation investigations and improvement projectsReview and approve laboratory investigations, ensuring root cause identificationSupport QA team members and assist in departmental trainingProvide support during regulatory auditsReview BOMs, inspection plans, pallet patterns, calibration records, and SOPsPerform internal audits and assist in audit report preparationMaintain and revise QA proceduresSupport Annual Product Review (APR) through data collection and database managementManage vendor complaint processesMonitor and trend deviations, laboratory investigations (LIs), CAPAs, customer complaints, and change controlsPerform special projects as assigned by Quality ManagementOversee and review obsolete material destruction processesConduct quality inspections on packaging lines as requiredMaintain supplier approval programsSupport and maintain site Document Control SystemReview, approve, and close Document Change RequestsTrack document changes using DCC tools and ensure closure of associated actionsMaintain document archives, including offsite storagePrint and issue controlled documents, forms, and logbooksReview documentation in eDMS for formatting and accuracyUpload and manage documents in the electronic Document Management System (eDMS)Route documents for approval within eDMS workflowsRetrieve documentation for audits in a timely mannerMaintain and revise document control proceduresKey Competencies (knowledge, skills, and abilities every person must possess to be successful)Strong critical thinking and problem-solving skillsExcellent customer service and professional communication skillsStrong verbal and written communication abilitiesEnergetic, motivated, and detail-oriented approachStrong organizational skills with attention to detailAbility to analyze data, identify trends, and make regulatory decisionsAbility to explain issues, propose solutions, and manage urgent requests effectivelyCapability to drive projects and implement process/system improvementsEducation/ExperienceBachelor’s degree in a scientific, quality assurance, or technical fieldMinimum 5+ years of relevant experienceStrong understanding of pharmaceutical cGMP, industry standards, and regulationsStrong cross-functional communication skills across different levels of the organizationExpertise in Quality systems and toolsProficiency in Microsoft Outlook, Excel, Word, and other web-based systemsStrong understanding of computer system validation and GAMP requirements #J-18808-Ljbffr