Assistant Manager - Production Deviation Investigator

Zydus Lifesciences

8 - 10 years

8 - 12 Lacs

ahmedabad

Posted:2 weeks ago| Platform:

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Skills Required

oos market complaints oot investigation deviation capa change control incident investigation

Work Mode

Work from Office

Job Type

Full Time

Job Description

Initiate and conduct investigations associated with sterile injectable product manufacturing and processing.
To identify true root causes through different tool and identify SMART CAPAs.
Review of investigations to ensure content of report in compliance to the site procedure requirements for its completeness, accuracy and adequacy.
To investigation market complaints, identify the root causes and respond to partner/customer.
To monitor overall investigations matrixes and present to management time to time.
Responsible for Quality compliance within the investigation process.
Actively involved in regulatory audits as a process SME.
Provide management timely updates on critical events.
To sustain excellence in investigation performance and maintain matrices meeting site targets.
Participate in CAPA idea generations and conduct risk assessments.
Responsible for Periodic trending of investigations and complaints.
Review and approve CAPA and Change Controls associated with investigation process.
Train the site colleagues as and when required.
Periodic review of guidelines and latest updates to identify CI actions at site.
To track manufacturing and supply schedule for enabling effective support.

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