About this role
Job Description
- Review analytical
methods for APIs and finished pharmaceutical products.
- Review analytical
method validation protocols and validation study
reports.
- Review API and
finished product specifications, limits, and acceptance
criteria.
- Review stability
study data and shelf-life justifications in line with ICH
guidelines.
- Review DMF analytical
sections and critical API quality attributes for
compliance.
- Verify analytical
compliance for BE study sample testing and reporting
activities.
- Identify analytical
documentation gaps impacting regulatory acceptability.
- Support preparation
of analytical-related responses to regulatory authority
queries.
- Verify alignment of
analytical data with CTD Module 3 structure and
expectations.
- Maintain accuracy,
traceability, version control, and integrity of analytical
records.
Requirements
- Bachelor’s or
Master’s degree in Pharmacy is mandatory.
- Minimum three years
experience in QC or analytical validation roles.
- Hands-on experience
reviewing analytical method validation documentation.
- Should have good
communication skills.
- Strong analytical
data interpretation and technical documentation review
skills.
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Benefits
- Remote working option
with defined review responsibilities.
- Flexible working
hours aligned to dossier and submission timelines.
- High technical
ownership without laboratory or shop-floor operations.