Pharma Gdp And Iso Specialist
Pharma GDP and ISO SpecialistBDP International - Segrate, Lombardia.
Job Description:
- To support to quality activities for storage, product handling, labelling and distribution operations.
Being responsible of the quality programs.
The responsibility also extends to the supervision and coordination of pharmaceutical products, country Healthcare regulatory requirements that are in line with the EU GDP, IATA CEIV and the BDP Global Pharma. .
Implement and maintain Quality Pharma Healthcare Management Systems with support of Country Quality Manager and Operations Manager.
Provide quality expertise to management, sales, and operations.
Interact with colleagues and with customers and regulatory partieies. .
Actively assure operational observance to compliance obligations to include, regulatory contractual and SOP driven requirements.
Look for ways to improve quality processes and procedures Develop plans to evaluate cost of quality improvements projects.
Create and implement self inspections plans with the alignment of Quality manager.
Being an official nominated and trained BDP Pharma Chain auditor and actively perform national Pharma and Healthcare audit.
Management of all anomalies and problems that may arise normal operations.
Monitoring of processes through specific Pharma KPIs and reporting to the local management in the yearly management review all Pharma relative tasks as mentioned in the global BDP pharma guidelines.
Management of the risk management system for any new processes or changes to existing procedures at leastonce a year. . Coordinating every kind of pharma complaint by setting up an adequate investigation with final closure through corrective and preventive actions in line with the global BDP Pharma guidelines.
Management of the entire quality process related to the pharmaceutical sector together with the Quality Manager.
Responsible for updates (both paper and system) of all the documentation relating to the regulations governing the handling, storage and transport of the pharmaceutical product, such as GDP legislation, IATA TCR, WHO annex guidelines 5 9.
Supervision of all local training activities related to the pharmaceutical service of BDP.
Supervising that all local BDP Pharma activities are done in line with the BDP Global Pharma guidelines, informing the Global Pharma Manager about KPI's, local pharma complains, new training needs and all necessary information the headquarter may need related to pharma.
activities.
Management of any type of internal and external audits related to the Pharma coming from institutions, customers, government authorities, associations etc.
Follows the performance indicators.
-5 years experience in operations. .
Minimum Graduate and additional qualifications in supply chain management will be helpful. .
Excellent knowledge of Quality Management Systems :
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