Senior Quality Reviewer: Data Integrity & Customer Quality

Piramal Pharma Limited; United States; Presencial; USD 90 000 - 130 000; Tempo integral

Resumo da oferta

Piramal Pharma Limited is seeking a Senior Quality Specialist, Customer Quality & Data Integrity, to independently review analytical and microbiology data and support batch disposition in a cGMP setting.

You will ensure records are complete, accurate, and inspection-ready, escalate data-integrity risks, and support customer deliverables with strong QA judgment and cross-functional collaboration.

Qualificações

• Bachelor’s degree in a scientific discipline is required.
• Minimum five years in a regulated life-sciences environment with cGMP QC.
• Experience reviewing analytical data is required; microbiology data preferred.
• Experience with LIMS, chromatography data systems, and electronic document systems.

Responsabilidades

• Perform independent review of analytical chemistry and microbiology records.
• Review laboratory data and certificates to ensure traceability and compliance.
• Evaluate investigations, deviations, CAPAs, and batch-release documentation.
• Assist in change controls, customer deliverables, and inspection readiness.
• Provide coaching on data integrity and Good Documentation Practices.

Formação académica

Bachelor’s degree in Chemistry, Biology, Microbiology, Pharmacy, Life Sciences, or related scientific discipline

5+ years of experience in pharmaceutical/regulated life-sciences with cGMP QC

Experience reviewing analytical laboratory data

Experience reviewing microbiology data (preferred)

Ferramentas

LIMS

Chromatography data systems

Electronic document systems (TrackWise, MasterControl, Veeva)

SAP

Descrição da oferta de emprego

Piramal Pharma Limited is seeking a Senior Quality Specialist, Customer Quality & Data Integrity, to independently review analytical and microbiology data and support batch disposition in a cGMP setting.

You will ensure records are complete, accurate, and inspection-ready, escalate data-integrity risks, and support customer deliverables with strong QA judgment and cross-functional collaboration.