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