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QS Pharmacist

Aspen Pharma Group • Other • Gqeberha, Eastern Cape, South Africa • $200 - $300 / year • 16h ago

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, including 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

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
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 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

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