Senior Quality Specialist: Data Integrity & Customer QA

Piramal Pharma Ltd; Sellersville (Bucks County); On-site; USD 105,000 - 145,000; Full time

Job summary

Piramal Pharma Solutions is seeking a Senior Quality Specialist to independently review analytical and microbiology data, ensuring accuracy, traceability, and readiness for approval in a cGMP environment.

You will support QA batch-record review, investigations, CAPAs, and change-controls, while escalating risks to management. Collaboration with QA, QC, and project teams is essential to deliver customer commitments.

Qualifications

• Bachelor’s degree in Chemistry, Biology, Microbiology, Pharmacy, Life Sciences, or a related scientific discipline is required.
• Minimum five (5) years of experience in a pharmaceutical, biotechnology, or regulated life-sciences environment, including substantial experience in a cGMP QC laboratory or Quality function.
• Demonstrated experience reviewing analytical laboratory data is required. Experience reviewing microbiology data is strongly preferred; role-specific qualification must be completed before independent approval.
• Working experience with batch records, laboratory investigations, OOS/OOT events, deviations, change controls, CAPAs, and product-impact assessments is preferred.
• Working knowledge of 21 CFR Parts 210 and 211, 21 CFR Part 11 as applicable, EU GMP, USP/EP requirements, data-integrity expectations, Good Documentation Practices, and risk-based Quality decision-making.
• Experience with laboratory and Quality systems such as LIMS, chromatography data systems, electronic document systems, TrackWise, MasterControl, Veeva, SAP, or comparable platforms is preferred.
• Experience supporting multiple products, customers, and concurrent deliverables in a CDMO/CMO environment is preferred.

Responsibilities

• Review analytical chemistry and microbiology records for batch disposition.
• Review electronic records, metadata, audit trails, and data integrity concerns.
• Support QA batch-record review and disposition with concise status updates.
• Review investigations, OOS/OOT events, deviations, change controls, and CAPAs.
• Draft, coordinate, and review customer change controls and supporting documentation.
• Provide coaching on data-review expectations and Good Documentation Practices.

Skills

Attention to detail

Scientific judgment

Written communication

Problem solving

Prioritization

Independent work

Education

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

Tools

LIMS

Chromatography data systems

Electronic document systems

TrackWise

MasterControl

Veeva

SAP

Job description

Piramal Pharma Solutions is seeking a Senior Quality Specialist to independently review analytical and microbiology data, ensuring accuracy, traceability, and readiness for approval in a cGMP environment.

You will support QA batch-record review, investigations, CAPAs, and change-controls, while escalating risks to management. Collaboration with QA, QC, and project teams is essential to deliver customer commitments.