Regulatory Compliance Pharmacist (Port Elizabeth) at Aspen Pharma Group

Job purpose

• 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.

Responsibilities

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 SOP’s 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