Manager

About the role

Preparation and review of hold time study protocols and reports. Release or rejection of finished products in SAP for market distribution. To check the maintenance of the department, premises and equipment/instrument We use the following session cookies, which are all required to enable the website to function:

What you'll do

• Review and Approval of master documents like SOPs, specification, STPs, OPML, batch manufacturing, batch packing records and stability protocol
• Review and Approval of quality system documents like change control, market complaints, deviation, OOS, OOT, CAPA etc. in QAMS
• Review and participation in investigation of deviations, market complaints, OOS/OOT, incidents etc
• Handling of recall and return goods, Field Alert Report, CAPA and participate in self inspection
• Review of validation protocols, annual product quality review of drug product

What you need

• 10–12 yrs of experience
• Stakeholder management
• SAP
• SOP writing
• Any graduate