Quality Inspector

PPL Healthcare LLC; Sellersville (Bucks County); On-site; USD 60,000 - 90,000; Full time

Job summary

Piramal Pharma Solutions in the United States seeks a Quality Operations Inspector to provide on-the-floor quality oversight, ensuring GMP/GDP compliance across manufacturing, packaging, labeling, and distribution. You will review batch records, perform line clearance, evaluate environmental data, and support regulatory alignment with data integrity standards.

A BS and 3 years of pharma QA experience are required, with strong analytical and communication skills.

Qualifications

• Bachelor of Science required; minimum 3 years in pharmaceutical quality assurance, regulatory affairs, or GMP auditing.
• On-the-floor quality oversight experience in a regulated environment preferred.
• Strong knowledge of GMP, GDP, GLP and FDA/EMA regulations.

Responsibilities

• Issue batch records aligned with production schedules and perform potency calculations as applicable.
• Conduct line clearance and batch readiness assessments.
• Review Environmental Monitoring data for compliance with internal standards and regulatory requirements.
• Review equipment logs and batch records for GDP/GMP/Data Integrity compliance.
• Draft, revise, and review QA SOPs and deviation reports.
• Conduct weekly quality surveillance activities including audits and inspections.

Skills

GMP/GDP knowledge

Data integrity

Analytical skills

Communication

Interpersonal skills

MS Office

Education

Bachelor of Science (BS)

Tools

MS Office

QMS software

Job description

Be the First to Apply Division Piramal Pharma Solutions Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia. This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation. Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide. For more details, please visit : www.piramalpharmasolutions.com

Job Title Quality Inspector Job Description

The Quality Operations Inspector is responsible for providing on-the-floor quality oversight and support to ensure the compliance of manufacturing, packaging, labeling, and distribution operations with Piramal Standard Operating Procedures (SOPs) and applicable regulatory requirements. This includes adherence to Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), Data Integrity principles, and FDA regulations. The inspector plays a critical role in maintaining product quality, safety, efficacy, and regulatory compliance across operations.

Key Responsibilities

• Issue batch records in alignment with the production schedule to support timely manufacturing activities and Perform potency calculations as applicable.
• Conduct line clearance and batch readiness assessments, including verification of concurrent documentation, equipment status, and preventive maintenance records.
• Review and evaluate Environmental Monitoring (EM) data for compliance with internal standards and regulatory requirements.
• Perform BMS alarms review, acknowledgement and evaluate quality impact.
• Escalate critical alarms to Management.
• Perform quality oversight for water system releases used in operations.
• Perform raw material Sampling and AQL inspection of finished products.
• Review equipment logbooks and executed batch records to ensure adherence to GDP, GMP, and Data Integrity standards.
• Scan reviewed batch records and upload to share point.
• Prepare batch records and perform first release of batches.
• Perform Raw material reconciliation and investigation.
• Review and approve Calibration activities in ProCal.
• Perform QA review and approval of non-routine workorders in SAP.
• Draft, revise, and review Quality Assurance SOPs and deviation reports to ensure clarity, accuracy, and regulatory alignment.
• Conduct weekly quality surveillance activities, including facility inspections, environmental monitoring checks, and audits of equipment maintenance and GMP practices to support continuous audit readiness.
• Complete all assigned training on SOPs and job-related tasks in a timely manner.
• Stay current with industry trends, updates to regulatory requirements, and emerging quality standards.
• Perform all other activities as assigned by Manager

Qualifications

Bachelor of Science minimum 3 years of experience in pharmaceutical quality assurance, regulatory affairs, or GMP auditing. minimum 3 years Prior experience in providing on-the-floor quality oversight and conducting inspections or working in a regulated pharmaceutical environment preferred.

Skills

• In-depth knowledge of GMP, GDP, GLP, and relevant international regulations (FDA, EMA).
• Strong analytical, attention to detail investigative, and problem-solving skills.
• Excellent communication (written and verbal) and interpersonal skills.
• Proficiency in MS Office and quality management systems (QMS).
• Ability to travel to facilities for inspections (as required).

Piramal 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.