Senior QA&RA Specialist | MedTech | Gauteng. Temp to Permanent Vacancy. at Salesworx Recruitment (Pty) Ltd

Job Description

Please note that this is a 6 month temp contract with the view to permanent employment at the end of the period. 

The role of Senior QARA Specialist is responsible for ensuring that CQA processes are in place in his / her region:

• Local Complaint Coordinator activity
• Product Surveillance activity for Medicinal Products and Medical Devices
• Field Action execution
• Supplier & Distributor Management:
• Implementation of Quality System in the region and audit management
• NCR, CAPA and Change Management
• Selling Authorizations and release of products according to local requirements
• Ensure back up persons for critical processes in the region are appropriately trained and back up are always available.
• To 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.
• To ensure that RA processes are in place in his / her region:
• To proactively monitor, review, interpret, and translate all national regulatory requirements of the Medicines Regulatory Authority
• To develop and implement strategies for earliest possible regulatory approvals to support business plans
• To maintain a good standing with the local regulators and to effectively manage the regulatory activities in line with the company expectations.
• To ensure appropriate contacts with country Supply Chain, Pharmacovigilance, TS, W&D and Businesses are maintained.

ESSENTIAL DUTIES AND RESPONSIBILITIES

As the Deputy Pharmacist of entity in South Africa:

• To 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
• To support the Quality activities of the Third-Party Logistics Warehouse in South Africa.

 Local Complaint Coordinator:

• To ensure a process and procedures are in place for the logging and investigation of complaints.
• To notify the authorities of reportable Complaints.
• To train the customer facing employees on complaints Handling Process.
• To close complaints with Customers and Authorities.
• To ensure backup LCC are appropriately trained and back up are always available.

 Country Product Surveillance activity for Medical Devices:

• To ensure effective gathering, recording, transmission to the Product Surveillance team and reporting to the competent Authorities of medical device adverse events.
• To 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.
• To set up and maintain an efficient Product Surveillance system in compliance with the national medical devices regulations and with the employers standards.
• To 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.
• To communicate with MOH and customers.
• To ensure timeous execution, reconciliation, and closure of FAs.
• To ensure back up local FA Coordinators are appropriately trained and back up are always available.

 Distributor Control:

• To manage the distributor/Third parties' assessment program.
• To perform and document Third Party audits and supervise the performance of corrective actions for deficiencies.
• To train distributors on QMS requirements.
• To sign QA agreements defining the company and distributors QA responsibilities.

 Supplier QA:

• To manage the supplier QA program of sponsoring Divisions for products and parts sourced in the region (in cooperation with Divisions).
• To maintain the approved supplier list.
• To sign QA agreements where applicable, defining the company and supplier QA responsibilities.

 Audit:

• To prepare for internal and external assessments and ensure positive outcomes.

 Training:

• To ensure that systems are in place and maintained to train employees in quality system compliance (including new SOP's).
• To ensure that training records are maintained.
• To ensure that Distributors and service providers are trained on GDP and the company’s requirements.
• To ensure training and implementation on new South African Health products Regulatory Authority (SAHPRA) guidelines.

 Compliance

• To ensure that workshops in the region comply with the requirements of applicable national laws and SOPs.
• To work with regulatory bodies on external audits & preparing responses
• To conducting Distributors GDP audits.
• To implement Good Distribution Practices within the region.
• To ensure release of products in accordance with local requirements.

 QMS & Documentation

• To implement applicable SOPs in the region.
• To ensure all relevant SOPs are in place to meet Corporate Quality Manual requirement and ISO 9001 and 13485 standards.
• To manage the preparation of new SOPs for the region, and the distribution, obsoleting & filing of quality documents.

 NCR, CAPA and Change Management:

• To timeously 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:

• To ensure that products are sold only to authorized entities and in full compliance with local regulations and company requirements.

 Become ERP System SME in the region:

• Expert of distribution related aspects of JDE and other ERPs.
• Ensure that back up for ERP expert user functions in his / her region are appropriately trained and back up are always available.
• Ensure process and procedures are in place for his / her region as applicable.

 Other Quality aspects:

• To manage temperature-controlled shipments in the region.
• To maintain and train backups of critical tasks (PQCs, MDRs, FAs, Releases).
• To define and control the quality aspects of third-party warehouses.
• To establish and maintain samples rooms (where required) within the company Scientific Offices in the region.

 Regulatory Affairs:

• Delivery of annual product submission plan
• Compiling / overseeing submission of dossiers according to annual product submission plan to Regulatory Authorities within the region.
• Due diligence on prospective dossiers from the company as well as 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 that recommendations are responded to timeously.
• Product registration Life Cycle Management: ensuring that necessary updates are made to the Registration Dossier according to latest requirements of the Regulatory Authorities.
• Ensuring timely approval of post registration variations to avoid out of stock.
• Ensuring that the Regulatory Authority is informed of changes to the registration dossier
• 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.
• Co-ordinating GMP/GCP inspections of parent company’s manufacturing facilities with inspectors from the various Regulatory Authorities.
• Controlling correspondence with other pharmaceutical companies and pharmaceutical consultants with regards to regulatory activities.

Requirements

Required Skills

• 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 able 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 flexible approach yet able to work unsupervised and under pressure
• Self-motivated with a high level of initiative

Role requirements

Experience:

• For a person with the specified education (see above) a at least 3 years professional experience is required in the quality and regulatory fields.
• At least 2 years of experience is required as Pharmacist.

Education

• A Pharmacy Degree is required.