Quality Systems Pharmacist
Aspen Pharma Group
2023-06-05 East London
Job Ref # : QSPHARM- QAEL03
Industry : Pharmaceutical And Medical / Healthcare
Job Type : Permanent
Positions Available : 1
Applications are invited for the above indicated vacancy that exists in the East London QA Department. The successful incumbent will report to the QS Team Leader. All applications are to be received on or before 12 June 2023. Preference will be given to Employment Equity candidates in line with Aspen’s Transformation Agenda.
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
Job Requirements
Responsibilities
QS coordination and supportProvide QA IT systems supportEnsure manufacturing processes, duties and activities are designed according to GMP and regulatory requirementsPerform process evaluation, including reporting of process and system deficiencies and following up on corrective actionsMaster data managementDefine and manage critical data relating to qualityEnsure adherence to product master data standards Master batch record (MBR) creation and validationCreate new item IDs on the ERPCreate and maintain precise, detailed and compliant manufacturing instruction / description documentation on the systemCheck 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 compliantEnsure proper MBR change controls in process compliance Procedure and document complianceAlign engineering and QA policies and configure system for cleaning and hold times, maintenance, calibration, and equipment taresImplement quality manuals and policiesConceptualise, initiate and author SOPs and process documents Identify, process and store records and review output documentsConduct reviews of protocols for product launches Audits and reportingConduct root cause analysis and risk assessments and reportParticipate in QMS monthly and annual reviewsConduct and report on statutory external (regulatory) audits Planning and operational supportProvide technical and operational input during drafting of quality plans and procedures specific to unitRequest, allocate and monitor the use of MES related assets and resources for the fulfilment of work objectivesStay up to date on developments, trends, legislation and regulationsProvide information for reports, as required by superiorRequirementsBackground / experience
Bachelor’s degree (B Pharm) with 4-6 years’ related work experiencePharmaceutical manufacturing experienceExtensive experience working with compliance procedures and administrative process automation Specific job skillsGood knowledge of local registrations and regulations and of international regulations / guidelines concerning GDP / GMP, QAAdvanced understanding of the pharmaceutical manufacturing and corrective action programsPharmaceutical standards and compliance requirementsExcellent computer / IT system administration skills CompetenciesInformation GatheringInterrogating InformationOffering InsightsEndorsing Quality StandardsAspen fully subscribes to the principles of Employment Equity and will make decisions in line with this ethos. Applications must apply on Direct Hire :
https : / / aspen.mcidirecthire.com / Internal / CurrentOpportunities
