QC DATA REVIEWER
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Experienced Quality Control professional with more than 20 years of experience in pharmaceutical analysis and GMP compliance. Skilled in HPLC, UV Spectrophotometer, Dissolution, calibration, analytical testing, documentation review, OOS/OOT investigation, and data integrity practices. Experienced in regulatory audits and maintaining compliance with USP, IP, BP, and cGMP requirements. Looking for opportunities in QC Data Reviewer, QA/QC roles in Ireland pharmaceutical industry.
17 Years Experience of Sun Pharma (India number one pharma company)
Worked in Quality Control department under cGMP/GLP environment in pharmaceutical manufacturing.
Extensive experience in analytical testing of raw materials, in-process samples, finished products, and stability samples.
Hands-on experience with HPLC, UV Spectrophotometer, Dissolution Apparatus, analytical balance, pH meter, and other laboratory instruments.
Performed instrument calibration, qualification, and routine verification activities as per SOP and USP requirements.
Reviewed analytical data, chromatograms, calculations, and laboratory documentation for GMP compliance.
Experience in OOS/OOT investigation, deviation handling, and data integrity practices (ALCOA+).
Knowledge of USP, IP, BP, and pharmacopoeial testing requirements.
Participated in regulatory audits including USFDA and international inspections.
Prepared and reviewed SOPs, analytical reports, specifications, and laboratory records.
Worked closely with QA and production teams to ensure compliance and product quality.
Strong understanding of GDP, GMP documentation, and laboratory compliance systems.
B.Sc
