Responsible Pharmacist - Q&R Manager
Fresenius Medical CareJohannesburg, Gauteng, South Africa22 hours ago
Job descriptionOversee the evaluation of the registration packages received from Principals. Identify and negotiate to obtain data identified as required in due diligence reports for registration of Medicinal Products and Medical Devices. Develop strategies which assist in negotiations with the Health Authorities to obtain registration approvals of Medicinal Products and Medical Devices for Regional Hub SSA business. Oversee the preparation and ensure the submission of new regulated product applications and registration by or before the target dates as well as the timeous submission of responses to deficiency letters received from the MOH’s. Prepare and / or manage the submission of appeals in response to negative decisions received from SAHPRA committees and other health authorities in SSA countries. Establish realistic timelines for the registration of products and effectively bring the Regional Hub SAA with the local regulatory backlog up to date. Ensure compliance to any applicable national requirements for the distribution of Medicinal Products and Medical Devices in the respective markets Establish and maintain a management system according to the national requirements Identify and implement effective processes and procedures for accomplishing compliance to documented CAPA’s. Plan, manage and control the day-to-day execution of regulatory affairs activities and drive improvement Maintain adequate records of registration activities and track registration submissions and approvals Keep up to date with respect to new legislation in countries of responsibility and advise the company on the impact of new legislation on current business. Develop strategies and systems to remain compliant locally and that are in line with Region requirements Establish and maintain relationships with the MOH’s, distributors, and key role players in the industry. Establish regulatory compliance regarding the sale of non-registered medicines - approved as Section 21 drugs Establish regulatory compliance regarding the sale of non-registered medicines - approved as Section 21 drugs Ensure the processing of all quality related product complaints, including traceability and CAPA logging. Implementation of MD vigilance and PV System (Responsibilities, Processes, CAPA`s, Training) in the respective area Ensure compliance with FMC`s MD and PV Processes Ensure that local ADR’s are reported as local legislation stipulates and inform Pharmacovigilance Corporate Drug Office. Ensure all learning requirement modules are actioned for the Regional Hub SSA personnel as well as AR’s for Export countries. Ensure around the clock monitoring and availability of dedicated identified reporting channels Ensure a functional recall system Qualification of contract manufactures, critical suppliers or service providers Creation and maintenance of Quality Assurance Agreements (QAA) with contract manufacturer, critical suppliers or service providers Implementation of QAA & PVA with all TPIs (Distributors) in the SSA Region, when applicable Creation and maintenance of supplier evaluation Ensure the activities are in compliance to the QAAs entered into the Regional Hub SSA Oversee QA functions are conducted compliantly to company policies and procedures and government regulations Performance, administration and documentation of annual self-inspections Performance of mock recalls Ensure the activities are in compliance to the Technical Agreements entered into the Regional Hub SSA. Ensure the compilation and implementation of documents required in order to remain compliant with the local regulators as per the local published and current acts and regulations, for the business continuity of Pharmaceutical and Medical device products. Packaging compliance and transition in the requirements to remain compliant to the region and practical for local system requirements and legislation Leading external and internal audits by ensuring that all required documentation is available and involved personnel are well prepared. Establishing the required CAPAs and ensuring that all actions are completed in compliance with established deadlines. Serves as responsible pharmacist in terms of the Medicines & Related Substances Act 101 of 1965 as well as Pharmacy Act 53 of 1974 Testing and release of Medicinal Products to bring into the market. Documentation Control Management Be familiar with the Global Management System, Internal company generated policies and procedures, in particular those pertaining to QA, Regulatory Affairs, Environmental, Pharmacovigilance and Compliance. Oversee the co-ordination and compliance to GDP within the QMS of the Regional Hub SSA Oversee the initiating, updating and maintenance of the company’s Documentation Control System. Follow and comply with all relevant FME policies, guidelines, manuals and SOPs in the version as amended from time to time ("FME Policies") Keep yourself updated about the current version of the FME Policies that are relevant for your role and integrate corporate values in daily business Pharmacy Honours Degree Functional related post graduate education (PhD, MBA) is a benefit Valid registration as a practising pharmacist with the SAPC Tertiary courses in Medicine Registration, Advertising Medicines, Quality Management system, GoodManufacturing Practices, Pharmacovigilance, and other related subjects Qualification in Medical Device and EHS Regulations preferred but not essential A minimum of 5 years of professional practice as a pharmacist Work experience in Quality and Regulatory affairs (> Strong and successful performance in an executive management role (>
Management and Steering
- Enables organization to harmonize and improve Q&R procedures, processes, infrastructure by the means of coordination, development and implementation of tools and the adaptation of globally provided contents into local business
- Create an efficient and effective management, organizational and operational structure.
- Establish and promote strong working relationships to HQ as well as counterparts and Business Partners in EMEA functions
- Stimulates cooperation and exchange of knowledge and experiences between all organizational units (from driving innovations)
Operations
Regulatory Registration Management
Regulatory Responsibilities
Sales and Marketing Support
Vigilance Management
Management of the Quality Assurance (QA) functions
Responsible Pharmacist responsibility
Quality, Legal & Compliance
1) Required training and education :
2) Required professional experience :
5 years)
5 years professional experience) in a healthcare or healthcare-related business environment, ideally in an international company
#J-18808-Ljbffr
Create a job alert for this search
Pharmacist • Johannesburg, Gauteng, South Africa
Related jobs
%20Ltd)
Ltd)
- Promoted
Clinical Pharmacist
Ultra PersonnelJohannesburg, Gauteng, South Africa Minimum Qualifications and Experience.Pharm and / MSc (Med) Pharm or M.Hospital experience is non-negotiable.Relevant operational experience and application of clinical pharmacy masters in a hospit...Show moreLast updated: 19 days ago
- Promoted
Senior Regulatory Affairs Manager
MNA RecruitmentGauteng, South Africa A leading pharmaceutical company has a vacancy for a Senior Regulatory Pharmacist to join their team.The responsibility of this position is to coordinate, project control and provide regulatory sup...Show moreLast updated: 30+ days ago
- Promoted
RA Pharmacist : Multinational generic PHARMACEUTICAL leader : Growing
WhizantsJohannesburg, South Africa Midrand-corporate office of growing multinational.Employer of choice with the best leadership and employee wellbeing.Growth is phenomenal offering the individual career-pathing and development.PHAR...Show moreLast updated: 30+ days ago
- Promoted
Clinical / DUR Pharmacist
Private Health Administrators (Pty) LtdCenturion, Gauteng, South Africa To ensure accurate and timely processing of chronic medicine reviews in alignment with client specifications, while providing expert clinical input to optimize medication management and patient out...Show moreLast updated: 3 days ago
- Promoted
Senior Regulatory Affairs Pharmacist
OttoBauthenticJohannesburg, Gauteng, South Africa Medicines Registration and Maintenance of Product Licenses with various Health Authorities in African countries.Submission of new pharmaceutical products for registration.Renewals of pharmaceutical...Show moreLast updated: 30+ days ago
- Promoted
Pharmacist - Thabong - New Store
Dis-Chem PharmaciesJohannesburg, Gauteng, South Africa Pharmacist - Thabong - New Store.Dis-Chem Pharmacies require the services of a reputable Pharmacist for their Thabong store.
Your portfolio will cover the provision of pharmaceutical care by taking ...Show moreLast updated: 30+ days ago
- Promoted
- New!
Responsible Pharmacist Deputy - Quality Manager
Fresenius Medical CareJohannesburg, Gauteng, South Africa Quality Management System (QMS).Implement, maintain, and improve the local QMS in alignment with global and regulatory standards.
Lead management reviews, internal audits, quality improvement projec...Show moreLast updated: 22 hours ago
- Promoted
Senior Regulatory Affairs Manager Gauteng
MNA RecruitmentGauteng, South Africa A leading pharmaceutical company has a vacancy for a Senior Regulatory Pharmacist to join their team.The responsibility of this position is to coordinate, project control and provide regulatory sup...Show moreLast updated: 30+ days ago
- Promoted
Senior Regulatory Affairs Pharmacist
Agility HR Solutions PtyMidrand, Gauteng, South Africa A global pharmaceutical company is seeking a Senior Regulatory Affairs Pharmacist with orthodox experience.Monitor and ensure compliance with regulatory guidelines and requirements.Stay updated wit...Show moreLast updated: 30+ days ago
- Promoted
Regulatory Affairs Portfolio Lead Prescription
Adcock IngramGauteng, South Africa Regulatory Affairs Pharmacist AI Prescription : Midrand.Timeous new product dossier submission, drive product registration, product life cycle management, compliance and meeting deadlines set by the...Show moreLast updated: 4 days ago
- Promoted
Pharmacy Manager - Rosebank Mall
Clicks Group LimitedJohannesburg, Gauteng, South Africa To ensure the efficient operation of the dispensary and the clinic and to ensure service excellence by leading and directing the pharmacy team to deliver high standards of Pharmaceutical care in or...Show moreLast updated: 30+ days ago
- Promoted
Clinical Pharmacist
The Good Human (Pty)LtdJohannesburg, South Africa We are seeking a dedicated and motivated Clinical Pharmacist to lead, manage, coordinate, and monitor clinical pharmacy services while driving pharmaceutical improvement within the hospital.The suc...Show moreLast updated: 30+ days ago
- Promoted
Regulatory AffairsPharmacovigilance Pharmacist
Air LiquideAlberton, Gauteng, South Africa How will you CONTRIBUTE and GROW.Provide assistance in order to develop implement and / or manage the Industrial Regulatory compliance process within a specific scope in accordance with the group P...Show moreLast updated: 17 days ago
- Promoted
Pharmacy Manager - Diepkloof
Clicks Group LimitedJohannesburg, Gauteng, South Africa To ensure the efficient operation of the dispensary and the clinic and to ensure service excellence by leading and directing the pharmacy team to deliver high standards of Pharmaceutical care in or...Show moreLast updated: 30+ days ago
- Promoted
- New!
Responsible Pharmacist Deputy - Quality Manager
Fresenius Medical Care North AmericaJohannesburg, Gauteng, South Africa Quality Management System (QMS).Implement, maintain, and improve the local QMS in alignment with global and regulatory standards.
Lead management reviews, internal audits, quality improvement projec...Show moreLast updated: 22 hours ago
- Promoted
Regulatory AffairsPharmacovigilance Pharmacist
AirgasAlberton, Gauteng, South Africa How will you CONTRIBUTE and GROW.Provide assistance in order to develop implement and / or manage the Industrial Regulatory compliance process within a specific scope in accordance with the group P...Show moreLast updated: 17 days ago
- Promoted
- New!
Responsible Pharmacist - Q&R Manager
Fresenius Medical Care North AmericaJohannesburg, Gauteng, South Africa Enables organization to harmonize and improve Q&R procedures, processes, infrastructure by the means of coordination, development and implementation of tools and the adaptation of globally provided...Show moreLast updated: 22 hours ago
- Promoted
Pharmacy Manager - The Islands
Clicks Group LimitedRoodepoort, Gauteng, South Africa To ensure the efficient operation of the dispensary and the clinic and to ensure service excellence by leading and directing the pharmacy team to deliver high standards of Pharmaceutical care in or...Show moreLast updated: 30+ days ago