QS Pharmacist at Aspen Pharma Group

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
• 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

• Requirements 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 Accountability and Decision Rights
• Demonstrate initiative and apply advanced concepts
• Exercise interpersonal, communication, training and problem solving skills to optimise team performance integrate resources for an area
• Escalate highly complex problems or out-of-policy issues Decisions relating to:
• Technical approach for project components, often in ambiguous situations, requiring advanced analytical skill, training/ education
• Establishing own work priorities and timelines Interpretation of policies, standards, requirements and approaches