Night-Shift Quality Inspector: GMP & QA Oversight

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

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.