Senior QC Investigator – Data Integrity & Lab Investigations

Piramal Pharma Limited; Northern (KY); On-site; USD 80,000 - 110,000; Full time

Job summary

Piramal Pharma Limited is seeking a Senior Quality Specialist in Quality Control to lead laboratory investigations (OOS/OOT), assess data integrity, and drive CAPA development in a cGMP environment. You will review chromatographic data, audit trails, and instrument outputs to ensure regulatory compliance and timely closure.

The role requires strong scientific judgment, cross-functional collaboration with QA, Manufacturing, and Regulatory Affairs, and hands-on experience with HPLC and data review

Qualifications

• Bachelor’s degree in a scientific discipline is required; advanced degree preferred.
• Minimum five (5) years of pharmaceutical QC laboratory experience in a GMP environment and data review.
• Experience authoring or leading laboratory investigations (OOS/OOT) and CAPA.
• Strong knowledge of FDA OOS/data-integrity guidance and 21 CFR Parts 210/211/11.

Responsibilities

• Lead and complete laboratory investigations with clear plan and timelines.
• Review paper and electronic laboratory records, chromatography data, metadata, and audit trails for data integrity.
• Develop and track CAPAs and verify effectiveness.
• Coordinate cross-functional teams to support investigations and product impact assessments.
• Review laboratory data and instrument outputs to ensure accuracy and traceability.

Skills

OOS/OOT investigations

Data integrity

Root-cause analysis

CAPA development

HPLC

Regulatory knowledge (FDA/21 CFR)

Education

Bachelor’s degree in Chemistry/ Analytical Chemistry/ Pharmaceutical Sciences/ Biology/ Microbiology

Tools

LIMS

Chromatography data systems

SAP

Instrument software

Job description

Piramal Pharma Limited is seeking a Senior Quality Specialist in Quality Control to lead laboratory investigations (OOS/OOT), assess data integrity, and drive CAPA development in a cGMP environment. You will review chromatographic data, audit trails, and instrument outputs to ensure regulatory compliance and timely closure.

The role requires strong scientific judgment, cross-functional collaboration with QA, Manufacturing, and Regulatory Affairs, and hands-on experience with HPLC and data review