Quality Inspector

piramalpharma; Sellersville (Bucks County); On-site; USD 70,000 - 90,000; Full time

Job summary

Piramal Pharma Solutions in Bucks County, PA is seeking a Quality Inspector to support GMP/GDP compliant manufacturing operations. The role involves batch record review, on-the-floor quality oversight, and maintaining data integrity across documentation and equipment logs.

You will perform material sampling, environmental monitoring review, calibration validation, and SOP deviation handling, with strong analytical and communication skills and willingness to travel to facilities as needed.

Qualifications

• Bachelor of Science degree required.
• Minimum 3 years of experience in pharmaceutical quality assurance, regulatory affairs, or GMP auditing.
• Minimum 3 years of on-the-floor quality oversight and inspections in a regulated pharmaceutical environment preferred.

Responsibilities

• Issue batch records aligned with production schedule.
• Perform potency calculations and line clearance assessments.
• Review Environmental Monitoring data for regulatory compliance.
• Oversee BMS alarms and escalate critical issues.
• Quality oversight for water system releases.
• Perform raw material sampling and AQL inspection.
• Review equipment logbooks and batch records for GDP/GMP and data integrity.
• Draft and review SOPs and deviation reports.
• Conduct weekly quality surveillance, including inspections and audits.
• Complete training on SOPs and tasks in a timely manner.

Skills

GMP/GDP/GLP knowledge

Regulatory knowledge

Analytical skills

Communication skills

MS Office

QMS familiarity

Travel willingness

Education

Bachelor of Science

Tools

SAP

MS Office

Job description

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

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).