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Company Name : Advanz Pharma
Location : Mumbai, Maharashtra
Position : Executive-Stability
Job Description : Main purpose of role:
To assist in management of stability studies including review of stability protocols, stability reports & study design with OOS/OOT investigations.
Key responsibilities (In Points):
Intimation of stability testing and follow up of stability reports with CMOs
Preparation and review of stability protocols for new studies
Assuring a suitable stability study number in stability software to every study initiated (On going)
Ownership of OOS/OOT investigations and ensure that the relevant agency/QP is notified
immediately once the results are confirmed
Unless otherwise justified, close all stability related deviation within 45 working days
Reduction of deviations cycle time in stability
Provide support to internal stakeholder by providing requested information on time
Prepare risk assessments, justifications, expert statement and RFI response for regulatory
submissions.
Supports CMO’s and contract labs in case of problems and arrangement of impurity /other
standards.
Managing the stability database on daily basis
Monthly reporting of Stability Metrics to Manager (on-going)
Review and perform impact assessment on stability management due to change control inside
the organisation
Participation in allocated internal/external audits (ongoing)
Negotiations with CMO’s and contract labs for quotation applied
Maintain professional standard at all times
To be punctual, maintain appropriate dress codes, be polite and courteous to internal and external customers
Demonstrate flexibility and willingness to assist
Methodical and hard working
This post is listed Under Mumbai jobs
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