Regulatory Quality Pharmacist
Aspen Pharma Group
2023/11/10   Port Elizabeth

Job Ref #: RQPNov23
Industry: Pharmaceutical And Medical/Healthcare
Job Type: Permanent
Positions Available: 1

Applications are invited for the above indicated vacancy that exists in the Pharma Affairs Department. The successful incumbent will report to the Quality Systems & Pharmaceutical Affairs Manager. All applications are to be received on or before 17 November 2023. Preference will be given to Employment Equity candidates in line with Aspen’s Transformation Agenda.

Job Description
  • 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.
Job Requirements

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