Pharma & Chem Job Openings at Topiox Research
Job Title: Bioanalytical Reviewer / QA Also can apply
Company Name: Topiox Research
Experience: 3 – 5 years
CTC: Open Budget (Hike on the current CTC)
Number of vacancies: above 1
Rounds of interview: 3 rounds Virtual
Qualification: BSc / M.Sc. In Pharmacy / Life Sciences / Chemistry
Location: Navi Mumbai
Job Summary:
We are looking for an experienced Bioanalytical Reviewer / QA – Bioanalytical professional to ensure the integrity, accuracy, and compliance of bioanalytical data generated during method development, validation, and sample analysis. The role will work closely with R&D, analytical, and QA teams to maintain documentation and regulatory readiness.
Key Responsibilities:
• Review bioanalytical method validation and sample analysis reports for compliance with regulatory guidelines (e.g., FDA, EMA).
• Ensure data integrity, traceability, and compliance with GLP/GMP and ICH requirements.
• Perform thorough reviews of raw data (chromatograms, calculations, etc.) and analytical reports.
• Oversee bioanalytical documentation including SOPs, protocols, and study reports.
• Participate in internal audits and support external audits or regulatory inspections.
• Coordinate with laboratory personnel to resolve data discrepancies and deviations.
• Contribute to quality risk assessments and CAPA implementation related to bioanalytical operations.
• Assist in maintaining quality systems for bioanalytical laboratories including instrument qualification and calibration records.
• Support regulatory dossier documentation and query responses related to bioanalytical sections (Module 5 of CTD).
• Ensure timely archival and retrieval of study documents and electronic data as per SOP.
Who Can Apply
• Bioanalytical scientists with QA responsibilities
• QA professionals from bioanalytical CROs/CDMOs
• Professionals involved in bioequivalence (BE) studies, PK/PD sample analysis, or LC-MS/MS data review
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