Quality Inspector - 3rd shift

Piramal Pharma Ltd; Sellersville (Bucks County); On-site; USD 65,000 - 90,000; Full time

Job summary

Piramal Pharma Solutions is seeking a Quality Operations Inspector for the 10pm–7am shift to provide on-the-floor quality oversight and support. The role ensures manufacturing, packaging, labeling and distribution comply with Piramal SOPs, GMP, GDP, data integrity principles, and FDA regulations.

Responsibilities include batch record review, line clearance, EM data assessment, SAP work order QA, and ongoing training to maintain audit readiness across operations.

Qualifications

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

Responsibilities

• Issue batch records and verify production readiness.
• Review environmental monitoring data for regulatory compliance.
• Perform QA review of non-routine work orders in SAP where applicable.
• Draft, revise and review Quality Assurance SOPs and deviation reports.
• Conduct weekly quality surveillance and facility inspections to support audit readiness.

Skills

GMP/GDP/GLP regulations

Regulatory knowledge (FDA/EMA)

Quality assurance on the floor

Communication skills

MS Office

QMS familiarity

Travel readiness

Education

Bachelor of Science

Job description

Division

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).