Job Ref #: QSPharm12
Industry: Manufacturing
Job Type: Permanent
Positions Available: 1

Job 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

• 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

Job 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