Senior CQA & RA Specialist, East & English Africa

Job Description

This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You’ll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter’s products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

Essential Duties and Responsibilities. 

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 back up 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 Baxter 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 Baxter QMS requirements.
• To sign QA agreements defining Baxter 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 Baxter 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 Baxter requirements.

Compliance

• To ensure that Baxter’s workshops in the region comply with the requirements of applicable national laws and Baxter’s 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 Baxter products in accordance with local requirements.

QMS & Documentation

• To implement applicable Baxter 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 Baxter requirements.

Become ERP System SME in the region:

oExpert of distribution related aspects of JDE and other ERPs.

oEnsure that back up for ERP expert user functions in his / her region are appropriately trained and back up are always available.

oEnsure process and procedures are in place for his / her region as applicable.

Other Quality aspects:

oTo manage temperature-controlled shipments in the region.

oTo maintain and train backups of critical tasks (PQCs, MDRs, FAs, Releases).

oTo define and control the quality aspects of third-party warehouses.

oTo establish and maintain samples rooms (where required) within the Baxter Scientific Offices in the region.

Regulatory Affairs:

oDelivery of annual product submission plan

oCompiling / overseeing submission of dossiers according to annual product submission plan to Regulatory Authorities within the region

oDue diligence on prospective dossiers from the company as well as other 3rd parties.

oDelivery of Future Registrations.

oContinuous liaison with Regulatory Authorities to ensure new product registrations are received on time to satisfy the requirements of the business.

oCompile / oversee that recommendations are responded to timeously.

oProduct registration Life Cycle Management: ensuring that necessary updates are made to the Registration Dossier according to latest requirements of the Regulatory Authorities.

oEnsuring timely approval of post registration variations to avoid out of stock.

oEnsuring that the Regulatory Authority is informed of changes to the registration dossier.

oPrinted Packaging Material Review: Review for compliance with the registered dossier and final approval before print.

oLiaising with the company head office on all regulatory activities.

oCo-ordinating GMP/GCP inspections of parent company’s manufacturing facilities with inspectors from the various Regulatory Authorities.

oControlling correspondence with other pharmaceutical companies and pharmaceutical consultants with regards to regulatory activities.

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.

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