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Division
Piramal Critical Care
Piramal 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
Principle Quality Assurance Compliance Specialist
Job Description
Provides continuous oversight of all daily Quality activities to assure compliance with internal procedures and regulatory requirements. Provide proper control, review, and management of site documentation to ensure GMP and regulatory compliance.
Essential Duties and Responsibilities
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 trainings
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 data bases
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 external audits and assist in writing reports for audits
Responsible for maintenance and revision procedures related to document control
May require up to 25% travel.