Release Pharmacist
Aspen Pharma España
Gauteng, South Africa
2d ago
source : findojobs-za

Description Overview Ensure in-process materials and finished products comply with GMP guidelines, regulation, and in-house SOPsDetermine product release for use into the marketplaceControl of documentation in compliance with regulation and company policies and proceduresRelated administrative tasks Requirements ResponsibilitiesPlanning and ProcessImplement and coordinate systems and procedures and make decisions within policies and procedures, or as authorised by superiors Product Release Review batch documentation and production conditions to assess compliance to quality procedures, standards and product specificationReview and approve quality of new, in-process and released batches to assess compliance to quality control programs, product specifications, and GMP guidelinesApprove and release production batchesExecute batch release priorities in line with OTIF and planning scheduleEnsure release requirements are met for finished productsDetermine disposition of in-process and finished products for clinical and commercial useEnsure changes / deviations in production or quality control have been approved according to QMSInitiate tests / checks / inspections / sampling to mitigate any risk associated with planned changes / deviationsEnsure production and QC documentation are completed in compliance with SOPsMonitor and audit compliance to regulatory and in-house standards with regards to current GMPReport observed deficiencies in process and follow up on corrective actionInvestigate systematic quality problems and develop preventative plans, in conjunction with ProductionProvide input into GMP-related training needs Reporting Complete and consolidate standard documentsFile, archive and retrieve documentsMaintain and update records and systems as required Skills requiredBackground / experience Bachelor’s degree in Pharmacy with 2-4 years’ related work experience, or PostGraduate Degree / Diploma with 1-3 years’ related work experiencePharmaceutical manufacturing experience Specific job skills Comprehensive knowledge of pharmaceutical manufacturing andcorrective action programs Pharmaceutical standards and compliance requirementsAbility to interpret and implement policies, processes and objectives Competencies Information GatheringInterrogating InformationMeeting DeadlinesFinalising OutputTaking Action Work Level Skilled Job Type Permanent Salary Market Related EE Position Yes Location Port Elizabeth

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