Requirements<\/p>\n
\tB. Pharm degree
\n\tActive Registration with the South African Pharmacy Council
\n\tcGMP skills
\n\tComputer literacy:\u00a0 \u00a0MS Office, Excel , Word , Power Point
\n\t3 years in Pharmaceutical Manufacturing environment
\n\t2 -3 years Quality Assurance experience
\n\tQMS and Pharmaceutical Knowledge<\/p>\n
Responsibilities:\u00a0<\/p>\n
\tTo ensure and maintain an effective Quality Management System in accordance with relevant regulatory and AI guidelines.
\n\tEnsure the handling and maintenance of all customer complaints are in compliance with SOPs.
\n\tEnsure that customer complaint samples are obtained from customers, where available, to aid in the investigation and customer complaint investigation\u00a0reports\u00a0are\u00a0reviewed\u00a0to\u00a0determine\u00a0the\u00a0adequacy\u00a0of\u00a0the\u00a0identified root cause and proposed CAPA\u2019s.
\n\tEnsure that critical customer complaints are reviewed and assessed immediately,\u00a0investigation\u00a0status,\u00a0progress\u00a0and\u00a0related\u00a0test\u00a0results\u00a0of\u00a0critical customer\u00a0complaints\u00a0are\u00a0followed\u00a0up\u00a0on\u00a0and\u00a0weekly\u00a0status\u00a0reports\u00a0of\u00a0critical complaints.
\n\tEnsure the management and close out of all AIL product customer complaints,\u00a0review\u00a0trends\u00a0including\u00a0that\u00a0of\u00a0recurring\u00a0complaints.\u00a0Conducting an Assessment of the identified risk to product quality, patient safety and product efficacy for complaints received, engage with various Stakeholders within the Business Units and the escalation of recurring complaints
\n\tEnsure that customer complaint training is provided to required Adcock Ingram staff.
\n\tEnsure handling of all Change Controls are in compliance with written procedures\u00a0and\u00a0appropriate\u00a0changes\u00a0are\u00a0documented\u00a0and\u00a0logged\u00a0with\u00a0GQA- QMS.
\n\tEnsure\u00a0the\u00a0review,\u00a0approval\u00a0and\u00a0close-out\u00a0Change\u00a0Controls\u00a0as\u00a0per\u00a0approved SOP\u00a0and\u00a0status\u00a0of\u00a0Change\u00a0Controls\u00a0are\u00a0reported\u00a0on\u00a0a\u00a0monthly\u00a0and\u00a0quarterly basis.
\n\tEnsure handling of all\u00a0Deviations are in\u00a0compliance\u00a0with\u00a0written procedures and root cause of a Deviation is investigated and documented, appropriate CAPAs are identified to address the root cause to prevent any re- occurrences.
\n\tEnsure that appropriate Deviations as set out in the Technical Agreements between\u00a0the\u00a0Applicant\u00a0(Adcock\u00a0Ingram\u00a0Limited)\u00a0and\u00a0each\u00a0respective\u00a0contract manufacturer\u00a0(Adcock\u00a0Ingram\u00a0and\u00a0non-Adcock\u00a0Ingram)\u00a0are\u00a0documented\u00a0and logged with GQA-QMS.
\n\tEnsure the review, approval and close-out of Deviations as per approved SOP and the status of Deviations are reported on a monthly and quarterly basis.
\n\tEnsure\u00a0handling\u00a0of\u00a0all\u00a0CAPAs\u00a0are\u00a0in\u00a0compliance\u00a0with\u00a0written\u00a0procedures\u00a0and appropriate CAPAs are identified to address the root causes of non- conforming\u00a0events\u00a0that\u00a0are\u00a0derived\u00a0from\u00a0various\u00a0sources\u00a0e.g.,\u00a0Customer Complaints,\u00a0Deviations,\u00a0Self-Inspections,\u00a0PQRs,\u00a0QMR,\u00a0Management Escalations
\n\tEnsure\u00a0the\u00a0review,\u00a0approval\u00a0and\u00a0close-out\u00a0CAPAs\u00a0as\u00a0per\u00a0approved\u00a0SOP\u00a0and status of CAPAs are reported on a monthly and quarterly basis.
\n\tEnsure an effective Self-Inspection program exists within the Applicant, Adcock Ingram Limited, which adequately measures compliance with GMP requirements.
\n\tEnsuring that Self-Inspections are conducted in accordance with an approved annual schedule and status reported on a monthly and quarterly basis in accordance with the approved procedure.
\n\tEnsure an effective recall system is implemented and managed in accordance with SAHPRA guidelines and the effectiveness of the Recall system\u00a0is\u00a0reviewed\u00a0and\u00a0assessed\u00a0periodically\u00a0by\u00a0conducting\u00a0a\u00a0Mock\u00a0Recall.
\n\tEnsure the implementation of CAPA\/s implemented due to the recall are completed and that the CAPAs effectiveness with sites or contract manufacturing are checked in accordance with the relevant CAPA procedure.
\n\tEnsure\u00a0that\u00a0training\u00a0on\u00a0Recall\/Withdrawal\u00a0Procedure is\u00a0provided\u00a0to\u00a0required Adcock Ingram staff.
\n\tEnsure that all records and registers are maintained and the close off of a recall following completion of CAPA and final reconciliation of returned product, distribution records and destruction certificate is obtained
\n\tReport on the progress of any recall initiated to the GQA Manager and AIL RP on a monthly and quarterly basis
\n\tManaging the preparation and execution of the Mock Recall and ensuring effective implementation of CAPAs identified.
\n\tReview of Technical agreements compiled between Adcock Ingram Limited\/Adcock\u00a0Ingram\u00a0Healthcare\u00a0and\u00a0a\u00a0Contract\u00a0Giver\u00a0noted\u00a0for\u00a0customer complaints,\u00a0Recall\u00a0responsibilities.\u00a0Ensure\u00a0that\u00a0all\u00a0Technical\u00a0Agreements\u00a0are tracked, logged on a register and stored in a secure location.
\n\tEnsure the effective management of the Management Escalation process and that all significant events reported to the Applicant are thoroughly investigated and appropriate CAPAs are implemented to prevent any re- occurrences
\n\tEnsure the status of Management Escalations are report on a monthly and quarterly basis in accordance with the approved procedures.
\n\tEnsure\u00a0that\u00a0all\u00a0Quality\u00a0related\u00a0documentation\u00a0is\u00a0controlled\u00a0in\u00a0accordance\u00a0with written procedures and that an effective documentation system exists to manage, the issuance of copies, track review dates of SOPs, hard copies and electronic copies of Master Documents, the distribution of SOP copies and the implementation, superseding and obsoleting of SOPs
\n\tThe review and authorization of QMS and other departmental SOPs are conducted timeously.
\n\tEnsure that the status of documentation \/ SOPs reported on a monthly and quarterly basis on to the GQA Manager
\n\tMaintaining and managing an effective Training procedure, which ensures continuity of management of various QMS processes and the development of GQMS department employees in accordance with the requirements of the SAHPRA guidelines
\n\tEnsure that all Job descriptions are reviewed and approved for the Quality Management Systems department in accordance with the approved procedure.
\n\tEnsure continuous training is provided to all employees within the QMS department in accordance with each employee\u2019s Training Plan and that the status of SOP training is reported on a monthly and quarterly basis.
\n\tManagement of the Quality Risk Management process by ensuring that a documented procedure is followed and providing support to all who need to perform Risk Assessments which shall be added to Adcock Ingram\u2019s Quality Risk Register whereby appropriate CAPAs are identified and implemented.
\n\tEnsure that the Quality Risk assessments conducted are reported on a monthly and quarterly basis in accordance with the approved procedures.
\n\tEnsure Stability and Analytical OOS results, as set out in the Technical Agreements between the Applicant (Adcock Ingram Limited) and each respective contract manufacturer (Adcock Ingram and non-Adcock Ingram) are documented and logged with GQA-QMS.
\n\tEnsure that an effective, accurate tracker\/register of all OOS reports logged are maintained and that OOS reports received are reported on a monthly and quarterly basis.
\n\tDepartmental management, preparation and participation in Contractual Partner Pharmacovigilance audits conducted by ensuring GQMS procedures are compliant with regulatory requirements and CAPAs identified are timeously implemented.
\n\tDepartmental management, preparation and participation in SAHPRA audits\u00a0by ensuring the GQMS procedures are complaint with SAHPRA requirements and CAPAs identified are timeously implemented.
\n\tby ensuring the GQMS procedures are complaint with SAHPRA requirements and CAPAs identified are timeously implemented.
\n\tManagement and escalation of all overdue QMS documentation namely, SOPs, change controls, Deviations, CAPAs, Self-Inspections, Management Escalations etc; to relevant departmental\/Functional Managers to ensure the effective implementation of Group QMS procedures.
\n\tPreparation and Execution of the Group Quality Assurance Quality Management Review conducted Quarterly in accordance with the procedure.
\n\tEnsuring effective management and implementation of Quality Management System Processes modules and other departmental modules via CaliberQAMS Electronic Systems.
\n\tEnsuring the administration of System Manager activities of the software are effectively managed by the CaliberQAMS administrator and that Disaster recovery and CaliberQAMS Reports are generated, reviewed and assessed as per the SOP.
\n\tEnsuring the registration of new Users and maintain existing users on the system in accordance with the approved procedures
\n\tEnsuring timeous logging of faults\/tickets by the CaliberQAMS system administrator on CaliberQAMS Support Portal Helpdesk System and resolution of faults by Caliber Technical Teams.
\n\tMonitoring the performance of the CaliberQAMS software in accordance with the approved procedure.
\n\tEnsuring monitoring of the QMS team, for closures of open Change controls, Deviation and CAPA\u2019s on the CaliberQAMS System.
\n\tManaging Internal Application audits conducted by Group Internal Auditing and ensuring the effective implementation of CAPAs identified.
\n\tWhere applicable, and within scope of authorised procedures, the delegation as a designee to review and sign documentation on behalf of the GQA Manager, GQA department Managers namely the CM Manager, PQR Manager, Audit Manager<\/p>\n
go to method of application \u00bb<\/p>\n
Apply via company website ( N \/ A ) or<\/p>\n
<\/p>\n","protected":false},"author":2,"featured_media":0,"template":"","meta":{"_promoted":"","_job_location":"","_application":"","_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-14947","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\/14947","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=14947"}],"wp:term":[{"taxonomy":"job_listing_region","embeddable":true,"href":"https:\/\/jobs.dataaxisnode.com\/southafrica\/wp-json\/wp\/v2\/job_listing_region?post=14947"},{"taxonomy":"job_listing_type","embeddable":true,"href":"https:\/\/jobs.dataaxisnode.com\/southafrica\/wp-json\/wp\/v2\/job-types?post=14947"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}