Deputy Manager - QA

Kalibre Global Konnects

10 - 15 years

12 - 15 Lacs

ahmedabad

Posted:1 week ago| Platform:

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Skills Required

capa gdp ipqa qms gmp market complaints investigation ccn

Work Mode

Work from Office

Job Type

Full Time

Job Description

To supervise all IPQA/QMS function activity on daily basis and update to Section Manager.
To conduct and participate in CAPA meetings and review summary report of the same within defined time period monthly.
To ensure the implementation of GMP, GDP practices and review of issues and impact of the same, if any, and take corrective actions.
To ensure the investigation for complaints and deviations and CAPA after reviewing instruments.
To prepare, review, Implement and update SOPs according to current regulations systems.
To review Master Batch Document (MBD) / Master Packing Document (MPD) and get approval in advance from Head of Department of Production & QA.
To train/update about new procedures and current guidelines or changes in international regulatory requirements.
To conduct CCN impact meeting and review the summary reports before sending for closure to Quality committee.
To respond to queries received from international regulatory affairs (IRA department/business partner/regulatory agency) and start change procedure and report the queries and response to reporting authority.
To carry out internal Audit in the plant.
To conduct daily morning meeting and review weekly/monthly departmental activity and report the same to reporting authority.
To ensure that all the deviations and OOS are reported to CQA for field alert Report assessment within required time frame.
To ensure and review of documentation of Change Control Notes and verify effectiveness of changes carried out.
To identify, monitor the deviation/abnormalities in process/documents/systems are captured and resolve them according to Quality management System.
To approve sample/good destruction process and to review and report any gap to reporting authority and take corrective and preventive action in co-ordination with respective reporting authority.
To prepare minutes of CAPA meetings.
To investigate complaints form markets.

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