Quality Systems 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

RequirementsBackground/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