Analytical QA Executive/Officer

Role & responsibilities-

• To ensure for cGMP followed by all personnels at non sterile Formulation.
• To approve Standard Operating Procedures pertaining to the Non Sterile Formulation.
• To ensure 21 CFR part 11 compliance to all Instrument, PLCs and computerized system.
• Online review/Audit of laboratory control system in accordance with cGMP/cGLP and standard operating procedure.
• Review and Approved of Stability Summary report.
• Review and approved of Analytical documents.
• Ensure implementation of Data Integrity Review System.
• To ensure Qualification and re-qualification of equipment and instruments, ensure for correctness of the report and approve the qualification reports.
• To ensure CFR part 11 compliance to all instruments, PLC's and computerized system.
• Ensure process validation, Cleaning validation, Analytical method validation and documentation for the same.