EU GMP Compliance
Ensure compliance with EU GMP.
Monitor adherence to EU GMP requirements and site
SOPs.
Support preparation and
execution of EU regulatory
inspections (EMA, EU Competent Authorities, customer audits).
Laboratory & Production Data Review for Dossier
submission
Review QC analytical data, raw data, and
laboratory reports for compliance with EU GMP and data integrity
requirements prior to submission for dossier submission.
Review Batch Manufacturing Record (BMR)
and Batch Packaging Record (BPR)
prior to submission for dossier submission.
Verify compliance of
critical process parameters, in-process controls, and analytical results
against approved specifications.
Batch Release Support
Ensure completeness and
compliance of documentation required for EU batch release.
Ensure compliance with MA dossier commitments.
Qualifications & Experience
Bachelor’s or Master’s
degree in Pharmacy, Pharmaceutical
Sciences, Chemistry, or Life Sciences.
Minimum15
years
of
experience in Quality Assurance
in a pharmaceutical manufacturing plant with EU GMP exposure.
Practical knowledge of EU GMP requirements for OSD and Oral Liquid facilities.
Experience in laboratory data review, BMR/BPR review,
and shop floor QA oversight.
Exposure to EU audits is mandatory.
Skills & Competencies
Strong understanding of EU GMP, data integrity, and regulatory
compliance.
Good documentation, review,
and investigation skills.
Ability to work
cross-functionally in a fast-paced export-oriented environment.
Inspection-ready mind set
with attention to detail.
Effective communication
skills (written and verbal).
