Description
Overview

• Performs product recipe functions (BOM, routing, master data management, master batch record creation, validation and change management) in MES
• Coordinates and supports administrative functions within QS

Responsibilities

• QS coordination and support
• Provide QA IT systems support
• Ensure manufacturing processes, duties and activities are designed according to GMP and regulatory requirements
• Perform process evaluation, including reporting of process and system deficiencies and following up on corrective actions
• Master data management
• Define and manage critical data relating to quality
• Ensure adherence to product master data standards
• Master batch record (MBR) creation and validation
• Create new item IDs on the ERP
• Create and maintain precise, detailed and compliant manufacturing instruction/ description documentation on the system
• Check that MBRs contain all pharmaceutically relevant data, including input material list, valid SOPs, detailed work instructions, process data/ steps (e.g. IPCs, CPPs, CQAs)
• Ensure that MBRs are GMP compliant
• Ensure proper MBR change controls in process compliance
• Procedure and document compliance
• Align engineering and QA policies and configure system for cleaning and hold times, maintenance, calibration, and equipment tares
• Implement quality manuals and policies
• Conceptualise, initiate and author SOPs and process documents Identify, process and store records and review output documents
• Conduct reviews of protocols for product launches
• Audits and reporting
• Store and manage retention samples as per guidelines.
• Conduct root cause analysis and risk assessments and report
• Participate in QMS monthly and annual reviews
• Conduct and report on statutory external (regulatory) audits
• Planning and operational support
• Provide technical and operational input during drafting of quality plans and procedures specific to unit
• Request, allocate and monitor the use of MES related assets and resources for the fulfilment of work objectives
• Stay up to date on developments, trends, legislation and regulations
• Provide information for reports, as required by superior

Requirements
Skills Required

Background/experience

• BPharm Degree with 4-6 years’ pharmaceutical manufacturing experience.
• Pharmaceutical manufacturing experience
• Extensive experience working with compliance procedures and administrative process automation

Specific job skills

• 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

• Information Gathering
• Interrogating Information
• Offering Insights
• Endorsing Quality Standards