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Further information
Role Overview:
Reporting to the Quality Compliance Leader, managing and implementation of the site Quality Compliance strategy. The Quality Compliance Coordinator works with the direct operational teams and RD function to enable the achievement of regulatory compliance and the âEU best practiceâEU initiatives within the factory.
Duties & Responsibilities:
Customer complaint investigation and reporting
Stability study review and investigation of deviations
Generating PQR data coordination of data review, report drafting
Generation and Publishing of weekly and monthly KPI reports
Provide support in preparation for and during regulatory audits
Co-ordinates weekly & monthly Customer complaints meetings, issues and minutes
Main Challenges:
Ensuring regulatory and RB Quality compliance
Maintenance and Management of site customer compliance investigations
Facilitations of PQR data generation & review process
Requirements
Degree in Chemistry or a related Scientific discipline.
Experience in pharmaceutical Good Manufacturing Practice (GMP)
Excellent organisational skills and ability to work across functionally
Experienced to audits, risk assessment and technical report writing
Ability to use Microsoft- Excel, Word and power point is essential
Excellent communication skills with the ability to work on own initiative is essential for the success of this role
