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.
• Conceptualize, 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

• 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

• 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. 

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