Lead - AQA (Analytical Quality Assurance)

Job Description

1. 1. Ensure the compliance with corporate policies (Quality, Safety, COBE etc... ).
   2. Planning and timely execution of activities related to analytical quality assurance.
   3. Review and release of exhibit and commercial batches as per agreed timelines.
   4. Review of cGMP (current Good Manufacturing Practices) compliance and adherence to norms.
   5. Review and approval of documents such as stability study, hold time study and cleaning validation study related protocols & reports.
   6. Review and approval of method validation, method transfers, method verification related protocols & reports as applicable.
   7. Review and approval of validation protocols and reports with respect to IQ/OQ/PQ for Facility, Area, Equipment, and Utilities as applicable.
   8. Review and approval of trend data of stability, water trends and environmental monitoring trend data as applicable.
   9. Evaluation, review and approval of risk assessments and change controls.
   10. Participation, review and approval of investigations, corrective actions and preventive actions pertaining to incidents / 00S / OOT.
   11. Review arid approval of specification and standard test procedures as applicable.
   12. To perform & participate the Internal and External audits.
   13. Imparting training to Quality Assurance personnel and new recruits.
   14. Verification and approval of standard operating procedures as applicable.
   15. To ensure timely completion of all related notifications as applicable.
2. 1. To prepare and review periodical trends of notifications, data presentation to senior management as applicable.
   2. To ensure adherence and implementation of applicable procedures in respective areas.
   3. To lead and develop a cohesive team to ensure appropriate capability and delivery.
   4. To participate and support continuous improvement projects
   5. To participate and follow safety, health and environmental procedures and practices.
   6. To carry any other activities assigned by upward reporting staff.

Qualifications

Education : M.Sc. 

Should be from AQA background only, from OSD background 

Exp : 10-12 Years

Mandatory : Should good communication skills, Should have experience in facing Audit

Should be well verse with Investigation, Digital System like LIMS, Empower

Should be from USFDA approved site only 

Should be Open to work at pydibhimavaram location