10 - 15 years
9 - 10 Lacs
Posted:-1 days ago|
Platform:
Work from Office
Full Time
1.Primary responsible to maintain and control an overall quality management system documentation and to monitor/supervision and control over the workman in their designated premises at the site.
2.Preparation and implementation of quality assurance policies and procedures.
3.Responsible for handling of change management system and co-ordination with regulatory affairs department for review and approval of change control documents related to process, facility, equipment related to product manufacturing.
4.Responsible for the preparation and review of investigation for market complaints, Deviations, incidents, product recall and other non-conformances.
5.Responsible for tracking, monitoring, review, implementation, closure and verification of corrective action and preventive action.
6.Responsible for self-inspection or internal audit and its compliance.
7.Responsible for Handling of risk management process at plant premises.
8.Responsible for conducting quality review meeting at plant.
9.Responsible for vendor qualification and review/compilation of vendor documents.
10.Preparation and review of the Quality manual, Quality policy, Data Integrity policy and site master file.
11.Ensure to implementation of cGMP, GDP, and data integrity in plant premises.
12.To review validation and qualification protocols and reports and facility layouts.
B. Pharma/M. Pharma with experience of QA (if Any)
Good communication and negotiation skills
Stanford Laboratories
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