Typical Accountabilities
• To support the implementation of, and adherence to, AstraZeneca Standard for Good Manufacturing Practices and
Good Distribution Practices in CAMCAR marketing company.
• Conduct activities and interactions consistent with Company values and in compliance with the Code of Conduct and supporting Policies and Standards relevant to GDP/GMP role.
• Complete all required training on the AZ learn, Code of Conduct, supporting Policies, and SOPs on time.
• Report potential issues of non-compliance.
• To support in the regular monitors & follow up of in the MC
• Ensure and monitor compliance by team members and third parties by
o Positively reinforcing the Code of Conduct and all relevant AstraZeneca Policies and SOPs
o Ensuring completion of all required training,
o Immediately escalation & reporting, as appropriate, instances of non-compliance. & Implement (CAPA) Corrective action & preventive actions
• Conduct Regular meetings with GXP or other quality leads where appropriate to discuss GDP/GMP quality issues &
agree on Corrective Actions And ensure this is discussed in management review meetings
• Support in the GRP implementation and communication with the regulatory department
• To maintain the GDP/GMP Quality system and continually improve its effectiveness.
• Regular Conduct of Self-assessment & respond to GDP/GMP check list.
• Ensure that GDP/GMP local & global Sops are followed among me team members to ensure implementation of
GDP/GDP
• Support Audit & Inspections with relevant GDP/GMP documents.
• Archiving & retrieve of GDP/GMP documents in line with AZ procedures
• Monitor Key Quality Compliance and Performance Indicators in GDP/GMP area and Regulatory area
• Monitoring KPIs in the related GxP area and proposing remedial and improvement actions
• Establishing improvement priorities
• Identifying trends and communicating identified risks
. To support the implementation of AZ Global Standard for GMP and GDP in the MC.
• To support in all Quality System implementation in operational tasks such as record, documentation and continuous monitoring.
• Comply with all local and global procedures.
• To regularly monitor compliance with the Global and Local standards of GMP/GDP.
• Providing/coordinating training and coaching in the related GxP area for the MC QMS.
• To maintain & support all Quality systems in the Region CAMCAR.
Education, Qualifications, Skills and Experience
Essential
. Holding a bachelor’s degree in business / operations
management/Pharmacist.
• Minimum three years of experience in this position
• Auditing experience &/or exposure to one of the GxP
area.
• Knowledge of spoken and written English (intermediate level)
• Good ability to learn and to adapt to work with IT
systems.
Desirable
• Educational qualification / certification in supply chain management
• Managerial experience in supply chain management of a pharmaceutical company
• Experience of working with stakeholders, distributors and third parties.
• Good knowledge on Microsoft Excel
Date Posted
25-may.-2021Closing Date
03-jun.-2021AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
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