Senior Quality Assurance Compliance Specialist

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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

Senior Quality Assurance Compliance Specialist

Job 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