Pharma Quality Inspector - GMP & Compliance

piramalpharma

Sellersville (Bucks County)

On-site

USD 70,000 - 90,000

Full time

6 days ago
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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

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.

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