Quality Assurance - QA OF QC | Ankleshwar

Job Location - Ankleshwar , Unit 2

Role & responsibilities

Person from background of Quality Control department will be more preferable.

• Responsible to ensure Good Laboratory Practices & compliance of QC SOP.
• Responsible for reviewing and approving the analytical reports Intermediate, Drug Intermediate, Drug Substance, stability report, Stability Protocol, Stability trend and instrument calibration.
• Responsible for reviewing and approving the stability & API analytical reports.
• Responsible for reviewing and approving the Working, Reference standard and COA.
• Responsible for issuance and retrieval of the controlled documents related to QC.
• Responsible to review Audit trails in the Laboratory softwares.
• Responsible to review user access privileges of instrument and compliance with requirements.
• Coordinate and provide documents pertaining to Drug Master File (DMF) filings.
• Responsible for review of specifications and standard testing procedure.
• Responsible for reviewing and approving of the Laboratory Instruments/ Equipments calibration.
• Responsible for technology transfer and related activities.
• Responsible for review of Stability summary trend.
• Responsible review of Risk Assessment report.

Preferred candidate profile

Total Experience Minimum 4 Years

Qualification - Msc Chemistry / BE chemical