Talent Manager at TMI Network
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General Manager/Head - Quality - Pharma (20-28 yrs)
We are looking for Quality Head at G.M -Level for 11,500 crore turnover company based in Hyderabad
Responsible for overall Quality Assurance / Quality Control Activities.
Responsible for release/rejection of Starting, In-process Materials and as well as Finished product as per MA specification and in accordance with GMP requirements.
Review and release of Batch Processing and Packaging records.
To ensure that production operations are carried out in accordance with GMP and applicable regulations.
To conduct GDP trainings and ensuring product dispatches in compliance with GDP requirements.
To conduct CGMP Trainings and ensure that awareness of GMP requirements are evaluated and updated through audits and periodic trainings as per training schedule and maintenance of training records.
To ensure that all changes are monitored through change/Exceptions Management module and to ensure complaint handling and investigation with appropriate measures to prevent reoccurrence.
Review and approve all documents/Minor Change Controls, Process non conformance, Material non conformance, Annual Product Review reports, Batch Cards in DMS Software, Product complaints, OOS, OOT and Failure investigation reports.
To follow and implement overall Quality Management System related procedures and Environment Management Systems related procedures.
Review and implementation of audit observation compliance report.
To ensure that a system is available to recall any batch of product from sale or supply and responsible to investigate the reasons for recall.
Responsible for CAPA coordinator activities.
To ensure compliance's of the validation protocols of facilities, equipment, process, cleaning, Analytical methods and system (HVAC and Water) and also to approve validation procedures and establish revalidation programs.
Handling of customers and regulatory inspections.
To ensure the compliance of Technical Agreements.
To authorize user ID creation for various operational softwares.
To ensure that plant hygiene including cleaning and sanitation.
To authorize documents in absence of Sr. Management Representative.
To ensure the compliance of the Empower and standalone software administration activities including back-up and restoration of the data.
Responsible for review and approval of Quality Risk Management exercises.
Other details :
Position reports to Corporate Quality Assurance
Based out of Hyderabad Bachupally at Unit 3 (OSD)
Salary we can go upto is Rs.40 lakhs
Experience: 20 years minimum
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