Quality Inspector - 3rd shift

Piramal Pharma Ltd; Sellersville (Bucks County); On-site; USD 55,000 - 75,000; Full time

Job summary

Piramal Pharma Solutions is seeking a Quality Inspector for the 3rd shift (10pm–7am) in Bucks County, PA. The role focuses on on-the-floor quality oversight to ensure GMP/GDP/GxP compliance across manufacturing, packaging, labeling, and distribution operations.

The successful candidate will review batch records, perform line clearance, monitor environmental data, and ensure data integrity in line with Piramal SOPs and FDA regulations.

Qualifications

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

Responsibilities

• Issue batch records in line with production schedule and perform potency calculations as needed.
• Conduct line clearance and batch readiness assessments with documentation/status checks.
• Review Environmental Monitoring data for compliance with internal and regulatory standards.
• Perform QA review of non-routine work orders and escalate critical alarms as needed.
• Review equipment logbooks and batch records for GDP, GMP, and data integrity compliance.
• Draft, revise, and review QA SOPs and deviation reports to ensure regulatory alignment.

Skills

GMP knowledge

GDP knowledge

GLP knowledge

Analytical skills

Communication skills

Problem-solving

Attention to detail

Education

Bachelor of Science

Tools

MS Office

Quality Management Systems (QMS)

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 - 3rd shift

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. This is a third shift position working from 10pm - 7am.

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).