Senior Quality Assurance Compliance Specialist

Piramal Critical Care, Inc.; Bethlehem (Northampton County); On-site; USD 90,000 - 130,000; Full time

Job summary

Piramal Critical Care, Inc. is seeking a Senior Quality Assurance Compliance Specialist to oversee daily QA activities, ensure GMP compliance, and manage documentation control.

The role involves review and approval of CoAs, regulatory readiness, and cross-functional collaboration to sustain quality across products. Ideal candidates have 5+ years of pharma QA experience, strong data analysis skills, and a proven ability to drive CAPAs, change controls, and audits within a global manufacturing

Qualifications

• Bachelor’s degree in a scientific, QA, or technical field.
• Minimum 5+ years of relevant experience in pharmaceutical QA/quality systems.
• Strong understanding of pharmaceutical cGMP, industry standards, and regulations.
• Cross-functional communication across different levels of the organization.
• Expertise in quality systems, validation, and GAMP requirements.

Responsibilities

• Review, approve, and disposition finished products; final CoA approvals.
• Coordinate investigations and CAPAs; manage change controls.
• Lead cross-functional deviation investigations and improvement projects.
• Support QA during regulatory audits and maintain document control.
• Maintain QA procedures and assist APR data collection and reporting.
• Manage supplier approvals and vendor-related activities.

Skills

Critical thinking

Regulatory decision making

Customer service

Professional communication

Attention to detail

Data analysis

Project management

Process improvement

Education

Bachelor’s degree in a scientific/QA/technical field

Tools

Microsoft Excel

eDMS (electronic Document Management System)

Validation tools / GxP software

Job description

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

Piralp Pharma Limited, offers a portfolio of differentiated products and services through its 17 global development and manufacturing facilities and a global distribution network in over 100 countries. PPL includes Piramal Pharma Solutions (PPS), an integrated Contract Development and Manufacturing Organization; Piramal Critical Care (PCC), a Complex Hospital Generics business; and the India Consumer Healthcare business, selling over-the- counter products. In addition, one of PPL’s associate companies, AbbVie Therapeutics India Private Limited is a JV with AbbVie Inc. and has emerged as one of the market leaders in the ophthalmology therapy area. Further, PPL has a minority investment in Yapan Bio Private Limited. In October 2020, PPL received a 20% strategic growth investment from the Carlyle Group.

PPL provides equal employment opportunities to all employees and applicants for employment. It prohibits discrimination and harassment based on race, color, age, sex, religion, national origin or ethnicity, disability status, genetics, protected veteran status, sexual orientation, gender identity, or expression, or any other characteristic protected by applicable law. Our employment decisions are based on merit considering qualifications, skills, performance, and achievements. Equal employment opportunity applies to all terms and conditions of employment, including recruitment, selection, training, social programs, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions.