To support the compilation and review of quality and regulatory documentation for regulatory submissions.
Ensure the effective quality and regulatory change management for products manufactured by facilities contracted by Aspen SA Operations.
Regulatory Compliance
Regulatory affairs evaluation and approval of Change Requests for relevant Aspen SA manufacturing and CMO sites.
Compile data packs for new product introduction projects or variations that are compiled for Aspen manufacturing sites or CMOs.
Define implementation timelines for post registration variations for Aspen SA Operations and CMO products to ensure variations are submitted in accordance with business requirements.
Provide regulatory intelligence and guidance on regulatory strategies for site projects.
Ensure compliance with regulatory guideline requirements pertaining to product registrations and variations.
Maintain and oversee the control of the product dossier IP where Aspen SA Operations is the MAH.
QS Management
Preparing and adhering to relevant process flows and SOPxe2x80x99s regarding quality system responsibilities.
Timeous management of records in the relevant Change Management Quality System,
Review and approval of required master documentation from relevant change request
Support any quality related processes in quality risk management, documentation management, or master data requests for Aspen SA Operations
Drive continuous improvement projects to improve efficiency and compliance within Aspen SA Operations.
Sub-contractor Change Management
Quality and Regulatory evaluation of Change requests for manufacturers/ distributors contracted by Aspen SA Operations
Advising and follow up on execution of supporting data required to ensure regulatory and quality compliance for change requests.
Ensure that CMOs comply with the latest regulatory GMP and product registration requirements.
Skills Required Background/experience
Matric/ Grade 12
BPharm Degree (Baccalareus Pharmacia)
2-3 years of experience in Pharmaceutical Manufacturing and/ or Quality Assurance Environment
Sound knowledge of Good Manufacturing and Good Documentation Practices
Knowledge of Regulatory Affairs and product dossiers
Computer literate
Specific job skills
Strong working knowledge of pharmaceutical manufacturing
Pharmaceutical standards and compliance requirements
Ability to interpret and implement policies, processes and objectives.
Ability to liaise with different people and build relationships.
Competencies
Offering Insights
Taking Action
Investigating Possibilities
Communication skills
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