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Purpose of the role
To perform product recipe functions (BOM, routing, master data management, master batch record creation, validation and change management) in Monitoring and Evaluation System MES.
Key Responsibilities
- Provide quality assurance IT systems support.
- Ensure manufacturing processes, duties and activities are designed according to GMP and regulatory requirements.
- Define and manage critical data relating to quality.
- Ensure adherence to product master data standards.
- Create and maintain precise, detailed, and compliant manufacturing instruction/ description documentation on the system.
- Ensure that MBRs are GMP compliant.
- Ensure proper MBR change controls in process compliance.
- Align engineering and QA policies and configure system for cleaning and hold times, maintenance, calibration, and equipment tares.
- Conceptualize, initiate and author SOPs and process documents Identify, process and store records and review output documents.
- Conduct root cause analysis and risk assessments and report
- Provide technical and operational input during drafting of quality plans and procedures specific to unit.
Minimum Qualifications & Experience
- Bachelor’s degree (B Pharm) with 4-6 years’ related work experience
- Pharmaceutical manufacturing experience
- Extensive experience working with compliance procedures and administrative process automation.
- Good knowledge of local registrations and regulations and of international regulations/guidelines concerning GDP/GMP, QA
- Advanced understanding of the pharmaceutical manufacturing and corrective action programs
- Pharmaceutical standards and compliance requirements
- Excellent computer/ IT system administration skills
Competencies (Skills, Behaviour & Knowledge)
- Information Gathering
- Interrogating Information
- Meeting Deadlines
- Finalizing Output
- Taking Action
Application Process
Medi Careers Specialist Recruiters is a division of Think-Career group and a proud member of the Federation of African Professional Staffing Organizations (APSO). You will now be redirected to https://www.thinkcareerrpo.com/ for a secure application process should you be interested to apply or register to be added to our talent community.
Disclaimer
Think-Career Group is dedicated to fostering diversity and inclusion in the workforce. We encourage applications from candidates of all backgrounds, experiences, and abilities who meet the minimum requirements of the job advertised. Our commitment to diversity extends to our clients, and we work diligently to connect talented individuals with opportunities that promote equality and inclusivity. We strive to ensure that every candidate receives fair consideration, free from discrimination or bias.
More Information
- Address South Africa
- Experience Level Specialist
- Total Years Experience 5
- Academic Qualification bachelor-degree
