JOB RESPONSIBILITIES
• Issuance of documents (SOP formats, logbook, register and LNB etc.) to cross-functional
departments based on request.
• Review of process development report/ Addendum to PDR/ Investigation report.
• Review and approval of Analytical Method Validation protocol and report.
• Review vendor qualification documents, vendor qualification report and performed vendor audit as
and when required.
• Review and approval of Specification and STP.
• Handling of QMS like change control, ...