Senior Quality Specialist, Data Integrity & Customer QA

Piramal Pharma Limited; Sellersville (Bucks County); On-site; USD 110,000 - 150,000; Full time

Job summary

Piramal Pharma Solutions in the United States is seeking a Senior Quality Specialist, Customer Quality & Data Integrity to independently review analytical and microbiological data and to support QA deliverables for batch disposition and customer programs in a cGMP setting.

You will ensure QC records and investigations are complete, accurate, traceable, and ready for Quality approval, applying ALCOA+ principles and raising risks to management when needed.

Qualifications

• Demonstrated experience reviewing analytical laboratory data.
• Experience reviewing microbiology data preferred.
• Working knowledge of cGMP, FDA 21 CFR Parts 210/211, Part 11.
• Experience with batch records, investigations, deviations, CAPAs.

Responsibilities

• Perform independent review of analytical chemistry and microbiology records.
• Complete QC data packages and support batch disposition.
• Review electronic records and apply ALCOA+ principles.
• Draft or review change controls and customer deliverables.
• Maintain inspection-ready documentation and trackers.

Skills

Analytical data review

Quality systems knowledge

Regulatory compliance

Education

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

Tools

LIMS

TrackWise

MasterControl

Veeva

SAP

Job description

Piramal Pharma Solutions in the United States is seeking a Senior Quality Specialist, Customer Quality & Data Integrity to independently review analytical and microbiological data and to support QA deliverables for batch disposition and customer programs in a cGMP setting.

You will ensure QC records and investigations are complete, accurate, traceable, and ready for Quality approval, applying ALCOA+ principles and raising risks to management when needed.