Explore a rewarding career as a QARA Specialist, ensuring pharmaceutical quality and compliance. Lead in complaints, product surveillance, regulatory affairs, and training initiatives. Be a key contributor to quality and compliance in the dynamic pharmaceutical sector.

The QARA Specialist – Deputy Pharmacist will be based in Johannesburg, South Africa.

At DNA Recruitment, we carefully review all applications and aim to contact every suitable candidate within max. 5 working days. If you don’t hear from us, please consider your application unsuccessful on this occasion.

Responsibilities

QARA Specialist: To ensure that CQA processes are in place in the region:

• QARA Specialist will be responsible for Local Complaint Coordinator activity.
• Product Surveillance activity for Medicinal Products and Medical Devices
• Field Action execution
• Supplier & Distributor Management: Implementation of the Quality System in the region and audit management
• NCR, CAPA, and Change Management
• Selling Authorizations and release of products according to local requirements
• QARA Specialist will ensure that backup persons for critical processes in the region are appropriately trained and make sure that backups are always available.
• To ensure that processes and procedures related to the mentioned activities comply with local regulations, the Corporate Quality Manual, and ISO 9001 and 13485 requirements.

QARA Specialist: To ensure that RA processes are in place in his / her region:

• Proactively monitor, review, interpret, and translate all national regulatory requirements of the Medicines Regulatory Authority
• Develop and implement strategies for the earliest possible regulatory approvals to support business plans
• Maintain good standing with the local regulators and effectively manage the regulatory activities in line with the company’s expectations.
• Qara Specialist will ensure appropriate contacts with the country’s Supply Chain, Pharmacovigilance, TS, W&D, and Businesses are maintained.

Deputy Responsible Pharmacist:

• Ensure company compliance with the Medicines and Related Substances Act the Pharmacy Act and cGMP in the control of medicines and medical devices distributed and sold by the company.
• Support the Quality activities of the Third-Party Logistics Warehouse in South Africa.
• Ensure a process and procedures are in place for the logging and investigation of complaints.
• Notify the authorities of reportable Complaints.
• Train the customer-facing employees on complaints Handling Processes.
• Close complaints with Customers and Authorities.
• QARA Specialist will ensure backup LCC are appropriately trained and backup is always available.

Country Product Surveillance Activity for Medical Devices:

• Ensure effective gathering, recording, transmission to the Product Surveillance team, and reporting to the competent Authorities of medical device adverse events.
• Collect, follow up, and transmit all local and near incidents to CTPS (Central Team Product Surveillance) using the Global tracking system and archive relevant documents.
• Set up and maintain an efficient Product Surveillance system in compliance with the national medical devices regulations and with the company’s standards.
• Ensure appropriate contacts with other functions such as Technical Services, Sales and Marketing, etc. that may be involved in this process.

Manage and Execute Field Corrective Actions:

• To be the local FA Coordinator, ensuring execution of FAs according to the Corporate, EMEA, and local Procedures.
• Communicate with MOH and customers.
• Ensure timeous execution, reconciliation, and closure of FAs.
• QARA Specialist will ensure appropriately trained backup local FA Coordinators. Ensure backup is always available.

Distributor Control:

• Manage the distributor/Third parties’ assessment program.
• Perform and document third-party audits and supervise the performance of corrective actions for deficiencies.
• Train distributors on QMS requirements.
• Sign QA agreements defining company and distributors’ QA responsibilities.

Supplier QA:

• Manage the supplier QA program of sponsoring Divisions for products and parts sourced in the region (in cooperation with Divisions).
• Maintain the approved supplier list.

Audit:

• QARA Specialist and Deputy Responsible Pharmacist will prepare for internal and external assessments and ensure positive outcomes.

Training:

• QARA Specialist will be to ensure that systems are in place and maintained to train employees in quality system compliance (including new SOPs).
• Ensure maintaining training records.
• Ensure that training for Distributors and service providers has been provided on GDP and company requirements.
• Ensure training and implementation of new South African Health Products Regulatory Authority (SAHPRA) guidelines.

Compliance:

• QARA Specialist will be responsible for ensuring that the company’s workshops in the region comply with the requirements of applicable national laws and the company’s SOPs.
• Work with regulatory bodies on external audits & prepare responses
• Conduct Distributor’s GDP audits.
• Implement Good Distribution Practices within the region.
• QARA Specialist will ensure the release of products following local requirements.

QMS & Documentation:

• QARA Specialist will implement applicable SOPs in the region.
• Ensure all relevant SOPs are in place to meet Corporate Quality Manual requirements and ISO 9001 and 13485 standards.
• Manage the preparation of new SOPs for the region and the distribution, obsoleting & filing of quality documents.

NCR, CAPA and Change Management:

• To initiate and investigate non-conformances (NCR) in the region and implement Corrective Actions and Preventive Actions as identified.
• To manage the Change Control process in the region.

Selling Authorizations:

• QARA Specialist will ensure the sale of products only to authorized entities and in full compliance with local regulations and requirements.

Become an ERP System SME in the region:

• Qara Specialist will be an expert on distribution-related aspects of JDE and other ERPs.
• Ensure appropriately trained and available backup for ERP expert user functions in his / her region
• Ensure processes and procedures are in place for his / her region as applicable.

Other Quality aspects:

• QARA Specialist will manage temperature-controlled shipments in the region.
• Maintain and train backups of critical tasks (PQCs, MDRs, FAs, Releases).
• Define and control the quality aspects of third-party warehouses.
• QARA Specialist will establish and maintain sample rooms (where required) within the company’s Scientific Offices in the region.

Regulatory Affairs:

• QARA Specialist will deliver the annual product submission plan
• Compiling/overseeing the submission of dossiers according to the annual product submission plan to Regulatory Authorities within the region.
• Due diligence on prospective dossiers from the company and other 3rd parties.
• Delivery of Future Registrations.
• Continuous liaison with Regulatory Authorities to ensure new product registrations are received on time to satisfy the requirements of the business.
• Compile/oversee timeously responding to recommendations.
• Product registration Life Cycle Management: ensuring that necessary updates are made to the Registration Dossier according to the latest requirements of the Regulatory Authorities.
• Ensuring timely approval of post-registration variations to avoid out-of-stock.
• Ensuring to inform the Regulatory Authority of the changes to the registration.
• Printed Packaging Material Review: Review for compliance with the registered dossier and final approval before print.
• Liaising with the company head office on all regulatory activities.
• Coordinating GMP/GCP inspections of the parent company’s manufacturing facilities with inspectors from the various Regulatory Authorities.
• Controlling correspondence with other pharmaceutical companies and pharmaceutical consultants about regulatory activities.

Responsible Pharmacist (Deputy):

Maintain compliance with the Medicines, Related Substances Act & the Pharmacy Act:

• Be certified as the deputy responsible pharmacist of the company in South Africa.
• Ensure company compliance with applicable Acts and guidelines:
• Continually supervise the company and delegate authority in writing to a pharmacist while absent from premises and notify the Pharmacy Council immediately when services as a Responsible Pharmacist have been or will be terminated.
• Ensure that unauthorized persons do not obtain access to medicines or scheduled substances or the pharmacy premises outside of normal trading hours.
• Establish, implement, and maintain policies and procedures for the distribution and sale of medicines and medical devices to ensure their safety, efficacy and quality.
• Ensure the safe and effective storage and keeping of medicines or scheduled substances.
• Ensure correct and effective record keeping of the purchase, sale, possession, storage, safekeeping and return of medicines or scheduled substances.
• Ensure no medicine or scheduled substance is sold by or to any person, or is in any person’s possession, except following the conditions prescribed in the Medicines Act.
• Initiate and coordinate all recall activities with Corporate Quality Management as well as SAHPRA.
• Ensure compliance with regulations to the marketing of medicines and code of practice.
• Advise SAHPRA who is authorized to communicate with them on behalf of the company.
• Ensure continued compliance with pharmacovigilance.  Advise the National Adverse Drug Event Monitoring Center (NADEMC) which is responsible for communicating with them.
• Take corrective measures in respect of deficiencies in inspection reports of the Pharmacy Council or in terms of the Medicines Act.
• Ensure high-quality assurance standards are maintained in the control of medicines and medical devices through a comprehensively designed and correctly implemented system of QualityAssurance incorporating Good Manufacturing Practice and Quality Control, which is fully documented and its effectiveness monitored, resourced with competent personnel, and suitable and sufficient premises, equipment and facilities.
• Ensure employees involved in quality control and distribution have appropriate education and training in principles of good manufacturing practice to perform assigned functions and receive regular training to remain familiar with applicable requirements.
• Conduct audits on systems, procedures, and operations to monitor compliance with and the effectiveness of GMP and QualityAssurance principles and to allow for improvement and corrective measures where required.
• Ensure Local Release of products in the country as per local regulations
• Prepare for MOH audits and ensure satisfactory outcomes.
• Be the interface with the third-party logistics and the TS third-party providers in all quality-related issues.

Qualifications for QARA Specialist & Deputy Responsible Pharmacist role

• Pharmacy’s Degree.    
• At least 3 years of professional experience in the quality and regulatory fields – required.
• At least 2 years of experience as a Responsible Pharmacist – required.
• Ability to liaise with internal and external stakeholders: Pharmacovigilance, W&D, Supply Chain, Compliance, Technical Services, Business, Regulatory Authorities, Third Party Partners
• Good Knowledge of GMP; GDP; ISO 9001 and ISO 13485
• Fluent in English and Afrikaans
• Stress resistance and ability to work in a rapid response environment
• Excellent communication skills, both verbal and written.
• Good organizational skills and the ability to multitask.
• Strong listening skills.
• Strong team player, with a flexible approach yet able to work unsupervised and under pressure
• Self-motivated with a high level of initiative

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