Job Description<\/p>\n
Please note that this is a 6 month temp contract with the view to permanent employment at the end of the period.\u00a0<\/p>\n
The role of Senior QARA Specialist is responsible for ensuring that CQA processes are in place in his \/ her region:<\/p>\n
\tLocal Complaint Coordinator activity
\n\tProduct Surveillance activity for Medicinal Products and Medical Devices
\n\tField Action execution
\n\tSupplier & Distributor Management:
\n\tImplementation of Quality System in the region and audit management
\n\tNCR, CAPA and Change Management
\n\tSelling Authorizations and release of products according to local requirements
\n\tEnsure back up persons for critical processes in the region are appropriately trained and back up are always available.
\n\tTo ensure that processes and procedure related to mentioned activities are compliant to local regulations, to the Corporate Quality Manual and to ISO 9001 and 13485 requirements.
\n\tTo ensure that RA processes are in place in his \/ her region:
\n\tTo proactively monitor, review, interpret, and translate all national regulatory requirements of the Medicines Regulatory Authority
\n\tTo develop and implement strategies for earliest possible regulatory approvals to support business plans
\n\tTo maintain a good standing with the local regulators and to effectively manage the regulatory activities in line with the company expectations.
\n\tTo ensure appropriate contacts with country Supply Chain, Pharmacovigilance, TS, W&D and Businesses are maintained.<\/p>\n
ESSENTIAL DUTIES AND RESPONSIBILITIES<\/p>\n
As the Deputy Pharmacist of entity in South Africa:<\/p>\n
\tTo ensure company compliance with the Medicines and Related Substances Act and the Pharmacy Act and cGMP in the control of medicines and medical devices distributed and sold
\n\tTo support the Quality activities of the Third-Party Logistics Warehouse in South Africa.<\/p>\n
\u00a0Local Complaint Coordinator:<\/p>\n
\tTo ensure a process and procedures are in place for the logging and investigation of complaints.
\n\tTo notify the authorities of reportable Complaints.
\n\tTo train the customer facing employees on complaints Handling Process.
\n\tTo close complaints with Customers and Authorities.
\n\tTo ensure backup LCC are appropriately trained and back up are always available.<\/p>\n
\u00a0Country Product Surveillance activity for Medical Devices:<\/p>\n
\tTo ensure effective gathering, recording, transmission to the Product Surveillance team and reporting to the competent Authorities of medical device adverse events.
\n\tTo collect, follow-up, transmit all local incidents and near incidents to CTPS (Central Team Product Surveillance) using the Global tracking system and archive relevant documents.
\n\tTo set up and maintain an efficient Product Surveillance system in compliance with the national medical devices regulations and with the employers standards.
\n\tTo ensure appropriate contacts with other functions such as Technical Services, Sales and Marketing etc. that may be involved in this process.<\/p>\n
\u00a0Manage and execute Field Corrective Actions:<\/p>\n
\tTo be the local FA Coordinator, ensuring execution of FAs according to the Corporate, EMEA and local Procedures.
\n\tTo communicate with MOH and customers.
\n\tTo ensure timeous execution, reconciliation, and closure of FAs.
\n\tTo ensure back up local FA Coordinators are appropriately trained and back up are always available.<\/p>\n
\u00a0Distributor Control:<\/p>\n
\tTo manage the distributor\/Third parties’ assessment program.
\n\tTo perform and document Third Party audits and supervise the performance of corrective actions for deficiencies.
\n\tTo train distributors on QMS requirements.
\n\tTo sign QA agreements defining the company and distributors QA responsibilities.<\/p>\n
\u00a0Supplier QA:<\/p>\n
\tTo manage the supplier QA program of sponsoring Divisions for products and parts sourced in the region (in cooperation with Divisions).
\n\tTo maintain the approved supplier list.
\n\tTo sign QA agreements where applicable, defining the company and supplier QA responsibilities.<\/p>\n
\u00a0Audit:<\/p>\n
\tTo prepare for internal and external assessments and ensure positive outcomes.<\/p>\n
\u00a0Training:<\/p>\n
\tTo ensure that systems are in place and maintained to train employees in quality system compliance (including new SOP’s).
\n\tTo ensure that training records are maintained.
\n\tTo ensure that Distributors and service providers are trained on GDP and the company\u2019s requirements.
\n\tTo ensure training and implementation on new South African Health products Regulatory Authority (SAHPRA) guidelines.<\/p>\n
\u00a0Compliance<\/p>\n
\tTo ensure that workshops in the region comply with the requirements of applicable national laws and SOPs.
\n\tTo work with regulatory bodies on external audits & preparing responses
\n\tTo conducting Distributors GDP audits.
\n\tTo implement Good Distribution Practices within the region.
\n\tTo ensure release of products in accordance with local requirements.<\/p>\n
\u00a0QMS & Documentation<\/p>\n
\tTo implement applicable SOPs in the region.
\n\tTo ensure all relevant SOPs are in place to meet Corporate Quality Manual requirement and ISO 9001 and 13485 standards.
\n\tTo manage the preparation of new SOPs for the region, and the distribution, obsoleting & filing of quality documents.<\/p>\n
\u00a0NCR, CAPA and Change Management:<\/p>\n
\tTo timeously initiate and investigate non-conformances (NCR) in the region and implement Corrective Actions and Preventive Actions as identified.
\n\tTo manage the Change Control process in the region.<\/p>\n
Selling Authorizations:<\/p>\n
\tTo ensure that products are sold only to authorized entities and in full compliance with local regulations and company requirements.<\/p>\n
\u00a0Become ERP System SME in the region:<\/p>\n
\tExpert of distribution related aspects of JDE and other ERPs.
\n\tEnsure that back up for ERP expert user functions in his \/ her region are appropriately trained and back up are always available.
\n\tEnsure process and procedures are in place for his \/ her region as applicable.<\/p>\n
\u00a0Other Quality aspects:<\/p>\n
\tTo manage temperature-controlled shipments in the region.
\n\tTo maintain and train backups of critical tasks (PQCs, MDRs, FAs, Releases).
\n\tTo define and control the quality aspects of third-party warehouses.
\n\tTo establish and maintain samples rooms (where required) within the company Scientific Offices in the region.<\/p>\n
\u00a0Regulatory Affairs:<\/p>\n
\tDelivery of annual product submission plan
\n\tCompiling \/ overseeing submission of dossiers according to annual product submission plan to Regulatory Authorities within the region.
\n\tDue diligence on prospective dossiers from the company as well as other 3rd parties.
\n\tDelivery of Future Registrations.
\n\tContinuous liaison with Regulatory Authorities to ensure new product registrations are received on time to satisfy the requirements of the business.
\n\tCompile \/ oversee that recommendations are responded to timeously.
\n\tProduct registration Life Cycle Management: ensuring that necessary updates are made to the Registration Dossier according to latest requirements of the Regulatory Authorities.
\n\tEnsuring timely approval of post registration variations to avoid out of stock.
\n\tEnsuring that the Regulatory Authority is informed of changes to the registration dossier
\n\tPrinted Packaging Material Review: Review for compliance with the registered dossier and final approval before print.
\n\tLiaising with the company head office on all regulatory activities.
\n\tCo-ordinating GMP\/GCP inspections of parent company\u2019s manufacturing facilities with inspectors from the various Regulatory Authorities.
\n\tControlling correspondence with other pharmaceutical companies and pharmaceutical consultants with regards to regulatory activities.<\/p>\n
Requirements<\/p>\n
Required Skills<\/p>\n
\tAbility to liaise with internal and external stakeholders: Pharmacovigilance, W&D, Supply Chain, Compliance, Technical Services, Business, Regulatory Authorities, Third Party partners
\n\tGood Knowledge of GMP; GDP; ISO 9001 and ISO 13485
\n\tFluent in English and Afrikaans
\n\tStress resistance and able to work in a rapid response environment
\n\tExcellent communication skills, both verbal and written.
\n\tGood organizational skills and the ability to multitask.
\n\tStrong listening skills.
\n\tStrong team player, with flexible approach yet able to work unsupervised and under pressure
\n\tSelf-motivated with a high level of initiative<\/p>\n
Role requirements<\/p>\n
Experience:<\/p>\n
\tFor a person with the specified education (see above) a at least 3 years professional experience is required in the quality and regulatory fields.
\n\tAt least 2 years of experience is required as Pharmacist.<\/p>\n
Education<\/p>\n
\tA Pharmacy Degree is required.<\/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":"Salesworx Recruitment (Pty) Ltd","_company_website":"http:\/\/N%20\/%20A","_company_tagline":"We partner with clients who look to us for sourcing talent across South Africa & EMEA. We specialize in sourcing outstanding sales talent from entry level to executive level. We collaborate with our clients to source talent across many job functions predominantly sales but also marketing, busine... read moress analytics, compliance, regulatory, finance and supply chain. We have a strong understanding of the talent needs of enterprise clients as well as small, medium and large companies. We have a rich pool of talent in our database with over 110k sales specific candidates. Our partnership with Linkedin enables us to seamlessly hunt talent according to your specific requirements.","_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":[18],"class_list":["post-22120","job_listing","type-job_listing","status-expired","hentry","job_listing_region-gauteng","job-type-contract"],"jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/jobs.dataaxisnode.com\/southafrica\/wp-json\/wp\/v2\/job-listings\/22120","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=22120"}],"wp:term":[{"taxonomy":"job_listing_region","embeddable":true,"href":"https:\/\/jobs.dataaxisnode.com\/southafrica\/wp-json\/wp\/v2\/job_listing_region?post=22120"},{"taxonomy":"job_listing_type","embeddable":true,"href":"https:\/\/jobs.dataaxisnode.com\/southafrica\/wp-json\/wp\/v2\/job-types?post=22120"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}