Manager - IPQA OSD
Manager - IPQA OSD
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Job Description
1. Finished product release
*Release of semifinished finished product process performance qualification and hold time study related analytical data for sterile formulation facility.
*Finished product batch release and approval of COA and COC for sterile products.
2. Investigation
*To conduct the thorough unbiased scientific investigation of the reported quality event.
*To review the investigation report.
3. Audit Compliance
*Review of selfaudit report and selfaudit compliance report.
*Carry out selfinspection along with the cross functional department personnel and compliance
*Handling of GMPaudit / inspection and coordination of compliance response to observations.
4. Complaint and Recall
*Preparation and review of the customer complaint investigation report.
*Preparation of Mock recall protocol / report and of Mock
Recall. Investigation of recall and returned products activity of drug product.
5. Unit Operation Verification
*To monitor the unit operation as per SOP.
6. Validation
*Preparation compilation and review of documents related to Process Performance Qualification Cleaning Validation Hold time study and other miscellaneous study.
*Review of equipment / system validation activities.
*Ensure that Validation Master Plan is appropriate adequate and followed /executed.
7. Qualification
*To identify the requirement of documentation and key stages in the qualification process.
*Review of User Requirement Specification (URS) Design Qualification (DQ) Installation qualification (IQ) Operation qualification (OQ) and Performance Qualification (PQ) document.
*Verification and evaluation of online qualification document.
*Review of Computer system validation documents.
8. In Process Quality Assurance (IPQA)Management
*Subject matter expert for In Process Quality Assurance activities.
*Manage and ensure smooth functioning of IPQA for Sterile Formulation facility by planning shift schedules prioritizing different tasks and allotment of activities to IPQA personnel.
*Monitoring and controlling the activities of IPQA section and tracking monthly productivity data and take corrective action to enable optimal utilization of resources.
*Involved in controlling implementing executing the activities of IPQA section.
*Monitor compliance to systems and processes by frequent shopfloor round.
*Monitoring cleanliness and environment control throughout the process in the manufacturing and packaging area.
9. QMS
*Preparation review of quality risk management report and coordination in quality risk assessment activity.
*Provide assigned training to the personnel. Review of Operator and Supervisor Qualification with assessment.
*Conduct periodic training for the team on Quality SOPs and cGMP training for other department
*Provide functional and technical guidance to the team through on the job coaching and support them in capability development
*Preparation and review of Critical Process Parameters Control Limits.
*Monitoring of Continuous Process Verification (CPV).
*Review and provide documents to facilitate timely regulatory and customer submissions.
*Review of SOPs and Protocols to ensure effective implementation.
*Initiation and Review of the Change Control as well as implementation of approved Change Control.
*Review of deviation with investigation and CAPA.
Required Experience:
Senior Manager
Employment Type
Full-Time
