Senior Quality Investigator - Lab Data & CAPA Lead

Piramal Pharma Limited; Sellersville (Bucks County); On-site; USD 90,000 - 120,000; Full time

Job summary

The Senior Quality Specialist, Laboratory Investigations & Data Integrity at Piramal Pharma Solutions leads laboratory investigations, OOS/OOT assessments, and CAPA development within a cGMP pharmaceutical laboratory.

Reporting to the Associate Director, Quality Control, the role applies scientific and regulatory judgment to determine root cause, assess product and data impact, document defensible conclusions, and drive timely actions to closure.

Qualifications

• Experience leading laboratory investigations in a cGMP environment.
• Familiarity with OOS/OOT assessments and CAPA processes.
• Strong focus on data integrity and compliant documentation.

Responsibilities

• Lead and complete laboratory investigations, including OOS/OOT assessments.
• Review analytical data and determine root cause and product impact.
• Document defensible conclusions and drive timely CAPA closure.

Skills

Laboratory investigations

OOS/OOT assessments

CAPA development

Data integrity

Job description

The Senior Quality Specialist, Laboratory Investigations & Data Integrity at Piramal Pharma Solutions leads laboratory investigations, OOS/OOT assessments, and CAPA development within a cGMP pharmaceutical laboratory.

Reporting to the Associate Director, Quality Control, the role applies scientific and regulatory judgment to determine root cause, assess product and data impact, document defensible conclusions, and drive timely actions to closure.