QA Compliance Manager - Epping, South Africa - Aspen Pharma Group

Aspen Pharma Group
Aspen Pharma Group
Verified Company
Epping, South Africa

3 weeks ago

Thabo Mthembu

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Thabo Mthembu

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Description
BASIC JOB FUNCTIONS (Brief Summary)
Purpose

  • Develop, manage, and monitor quality procedures, standards, and specifications for value streams in compliance with
regulations.

  • Manage and monitor core QA activities for value streams.
  • Review and approve inprocess QA programs and activities.
  • Responsible for Compliance with cGMP activities on site.
  • Performance management of direct reports.
Planning & Processes

  • Interpret, implement, and coordinate systems, processes, policies, and procedures contributing to the quality assurance
for the site.

  • Provide input into existing systems, procedures and policies that impact inprocess control activities in value stream
operations and quality for the site.
Financial & Resource Management

  • Provide input into the functional financial plan/ budget based on operational requirements
  • Ensure availability and optimal allocation of resources within the department
People Management & Development

  • Implement human resource policies
  • Participate in training, coaching, and development for team members
  • Develop and implement performance contracts and succession plans
  • Manage conflict, disciplinary, and safety issues
  • Assist with recruitment
Process Compliance

  • Review and approve Deviations and CAPA plans to address systematic issues.
  • Review and approve operational changes to SOPs and processes
  • Participate in Risk Assessments
  • Review and update MBPRs as required
In Process Quality Management

  • Review and approve the process for inprocess quality management
  • Governance, Risk & Compliance
  • Ensure site activities comply with operating guidelines and policies for the organisation and function.
  • Monitor and correct compliance with legislation, policies and procedures to impact on the effectiveness of QMS

COMPETENCIES

  • Planning and organizing. Exceptional attention to detail and accuracy.
  • Excellent report writing and document reviewing skills.
  • Interrogate information.
  • Uncompromising individual integrity and work ethic.
  • Exercise interpersonal skills, communication, training and problemsolving skills to optimize team performance.
  • Managing performance
  • Proven leadership skills, selfdriven and motivated.

JOB SPECIFICATIONS:

  • Minimum requirement BSc, BTech, Degree in Natural Sciences or Engineering or equivalent as per the National
Qualifications Framework

  • 5 years of related work experience in a laboratory or preferably chemical manufacturing operation.
  • Pharmaceutical manufacturing experience.
  • Computer proficiency in MS Office and SAP.
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