Jobs in Go!

To support the overall Validation Program by conducting qualifications and preparing and/or executing validation documents. This includes the generation, development, modification, and routing of Validation Protocols, Final Reports, Standard Operating Procedures, and Change Controls. Validation systems are in place and used to control/ guarantee the quality of products. Responsibilities of the Role: Execute-validation documentation in line with the standard approval process/protocolsMaintains matrices for all departmentsCommunicate and liaise with all stakeholdersImplement process improvement initiativesPerform root cause analysis of system failuresUpdating existing quality documentationIdentifying training requirementsMaintains accurate and complete safety /GMP records with company policy and legal requirementsAdministers troubleshooting efforts for protocol discrepanciesIdentify process gaps and apply process improvement methodologiesPlan, prioritize process improvement initiativesExplores process improvement opportunitiesIdentify and communicate any skills/training requirements to help execute tasks efficiently.Develop validation documents with functional teams, ensuring the documentation meets regulatory requirements and quality standardsTo ensure that new and updated Guidelines and Policies from SAHPRA and other Regulatory bodies related to pharmaceutical industry are used at all times when developing internal documentationInterface with customers to ensure concerns and complaints are communicated and corrective actions are closed in a timely mannerTo ensure that all validation related audit points identified during audits are closed timeouslyWrite, review Protocols, Deviations, Final Reports, SOPs, and Change Controls with emphasis on process validation. Minimum Requirements: Bachelor's Degree in Science/Engineering or a related disciplineExperience in pharmaceutical industry with the manufacturing environmentAt least 2 years in a Validation DepartmentGood working knowledge of manufacturing equipment, process, facility, utilities and computerised system validationProficiency in MS Office (Word, Excel, PowerPoint and Project management)Ability to interpret and relate validation guidelines and standards for implementation to functional areasDemonstrated ability to provide technical solutions for problems through process knowledgeProficient in the use of structured problem-solving tools such as Process Mapping, Root Cause Analysis, Failure Mode effects analysis, etc. Core Competencies: Presenting and communicating informationApplying expertise and technolog https://protool.gumtree.co.za/external-link-browser.html?urlaHR0cHM6Ly93d3cuZGl0dG8uam9icy9qb2IvZ3VtdHJlZS8yNzAxMTY4MTA4P3NvdXJjZT1ndW10cmVl&jid1322070&xid2701168108 Apply Now

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Jobs in Go!