Key Job Output<\/p>\n
Legal compliance to SAHPRA\/PICs, cGMP requirements and Pharmacy Council requirements.<\/p>\n
\tTo ensure that all validation related audit points identified during internal and external audits are closed timeously.
\n\tTo ensure that new and updated Guidelines and Policies from \u00a0SAHPRA and other Regulatory bodies related to pharmaceutical industry are used at all times when developing internal documentation.<\/p>\n
Qualifications and Validations<\/p>\n
\tCompiling and updating \u00a0a Validation Master Plan (VMP) and relevant Validation Plans (VPs).
\n\tEnsuring the qualification of all facilities and utilities \u00a0areas as per Validation Schedule.
\n\tStandardising validation approach ensuring consistency of application in accordance with agreed timelines and schedules.
\n\tEnsure qualification of all equipment and validation\u00a0 of \u00a0processes as per the equipment train and product portfolio.
\n\tEnsuring the requalification and\/or periodic reviews of all qualified equipment and utilities as per Validation Schedule.
\n\tComprehension of sterile manufacturing concept and associated processes such as the media fill, media hold, dirty and clean hold time studies.
\n\tDetermining test requirements and detection limits for validation samples to the Laboratory.
\n\tCoordinating site calibration activities for all critical instruments and equipment.
\n\tSamples Analyzed and report all non-conformances and failures.
\n\tProviding recommendations and guidance on \u00a0changes related \u00a0to manufacturing process, equipment and \u00a0procedures.
\n\tPerforming cleaning validations and ensure that the cleaning validation matrix for all departments is maintained, protocols and reports are prepared in time.
\n\tProficiency in computerised system validation and application of relevant guidelines such as 21 CFR 11 Part 11, PIC\/S Annex 11, GAMP 4, GAMP 5 etc.
\n\tCompiling and updating departmental SOPs, protocols and reports.
\n\tProficient in the use of structured problem-solving tools and Quality Management System such as RCA (Root Cause Analysis), FMEA’s (Failure Mode effects analysis), Change Control, Deviation, Corrective and Preventative Actions etc. \u00a0
\n\tProficiency in project management and use of relevant tracking tools.
\n\tManaging budget, operating and capital expenses. \u00a0<\/p>\n
Self-development<\/p>\n
\tStudy new guidelines and policies from SAHPRA\/PICS to keep abreast with developments and changes with regards to legal aspects and regulatory requirement pertaining to pharmaceutical, product manufacturing.
\n\tIdentify and communicate any skills\/training requirements to help execute tasks efficiently.<\/p>\n
Time Management and Self Discipline<\/p>\n
\tTo ensure time keeping at all times
\n\tTo ensure that tasks allocated to individuals are performed and presented in time as scheduled<\/p>\n
Requirements<\/p>\n
\tDegree within Natural Sciences or Engineering
\n\tMinimum of 5 years in pharmaceutical validation experience of which 2 years must be as a Validation Manager.<\/p>\n
Apply via company website ( N \/ A ) or<\/p>\n
adcock.mcidirecthire.com<\/p>\n
<\/p>\n","protected":false},"author":2,"featured_media":0,"template":"","meta":{"_promoted":"","_job_location":"","_application":"http:\/\/adcock.mcidirecthire.com","_company_name":"Adcock Ingram","_company_website":"http:\/\/N%20\/%20A","_company_tagline":"Adcock Ingram is a leading South African pharmaceutical company with a proud 130 year heritage. It has a portfolio of trusted, quality brands and generics and an entrenched value system that assures integrity. Growing from humble beginnings as a small Krugersdorp pharmacy in 1890, Adcock\u2019s portfo... read morelio includes an extensive range of Prescription, Over-the-counter (OTC), Consumer and Hospital products and life saving hospital products.","_company_twitter":"","_company_video":"","_filled":0,"_featured":0,"_remote_position":0,"_job_salary":"","_job_salary_currency":"","_job_salary_unit":""},"job_listing_region":[11],"job-types":[12],"class_list":{"0":"post-14808","1":"job_listing","2":"type-job_listing","3":"status-expired","4":"hentry","5":"job_listing_region-gauteng","7":"job-type-full-time"},"jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/jobs.dataaxisnode.com\/southafrica\/wp-json\/wp\/v2\/job-listings\/14808","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/jobs.dataaxisnode.com\/southafrica\/wp-json\/wp\/v2\/job-listings"}],"about":[{"href":"https:\/\/jobs.dataaxisnode.com\/southafrica\/wp-json\/wp\/v2\/types\/job_listing"}],"author":[{"embeddable":true,"href":"https:\/\/jobs.dataaxisnode.com\/southafrica\/wp-json\/wp\/v2\/users\/2"}],"wp:attachment":[{"href":"https:\/\/jobs.dataaxisnode.com\/southafrica\/wp-json\/wp\/v2\/media?parent=14808"}],"wp:term":[{"taxonomy":"job_listing_region","embeddable":true,"href":"https:\/\/jobs.dataaxisnode.com\/southafrica\/wp-json\/wp\/v2\/job_listing_region?post=14808"},{"taxonomy":"job_listing_type","embeddable":true,"href":"https:\/\/jobs.dataaxisnode.com\/southafrica\/wp-json\/wp\/v2\/job-types?post=14808"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}