CQA Senior Specialist Emerging Africa
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Job Location:
Monthly Salary:
Posted on:
25 days ago
Vacancies:
1 Vacancy
Job Summary
This is whereyour work makes a difference.
At Baxter we believe every personregardless of who they are or where they are fromdeserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today tomorrow and beyond.
Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together our community is driven by a culture of courage trust and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations and we hold each other accountable for delivering exceptional results.
Here you will find more than just a jobyou will find purpose and pride.
About the Role
We are looking for a highly motivated Senior Country Quality Assurance Specialist to join Baxters Quality Assurance & Regulatory Affairs team for Emerging Africa (North & East Africa region).
In this role you will ensure compliance with local and corporate quality systems manage product vigilance and field safety activities and support distributors and suppliers across the region.
This position requires a strong understanding of GMP GDP ISO 9001 ISO 13485 and regional regulatory frameworks as well as excellent communication and leadership skills.
Key Responsibilities
Act as Local Complaint Coordinator ensure logging investigation and closure of product complaints.
Oversee Product Surveillance for medical products and devices including vigilance field safety notifications and reporting.
Manage and execute Field Corrective Actions (FCA) and CAPA processes.
Lead Distributor and Supplier Quality Management including audits and performance monitoring.
Manage Change Control NCRs and Deviations in compliance with corporate and local requirements.
Ensure proper Product Release and selling authorization according to regulatory standards.
Conduct and support Internal and External Quality Audits (GDP GMP).
Oversee QMS & Documentation including creation and implementation of SOPs.
Provide training and guidance to internal teams and partners on quality systems and compliance.
Collaborate with regulatory authorities and internal stakeholders (RA PV TS W&D Supply Chain).
Qualifications & Skills
Minimum 5 years of experience in Quality Assurance or Regulatory Affairs in the pharmaceutical or medical devices sector.
Fluency in English (French is a strong advantage).
Proven experience with auditing (internal/external).
Strong background in NCRs Deviations CAPA Change Control and QMS.
Experience with Distributor and Supplier Management.
Knowledge of product vigilance and field safety actions.
Excellent communication organizational and multitasking skills.
Ability to work independently with high initiative and accountability.
No specific university degree required but a degree in Pharmacy or Life Sciences is an advantage.
Why Baxter
At Baxter we are deeply committed to saving and sustaining lives. This role provides the opportunity to make a direct impact on patients safety and product quality across Emerging Africa. You will join a collaborative team work in an international environment and contribute to ensuring that our products meet the highest standards of quality and compliance.
Equal Employment Opportunity
Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race color religion gender national origin age sexual orientation gender identity or expression protected veteran status disability/handicap status or any other legally protected characteristic.
Reasonable Accommodations
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If because of a medical condition or disability you need a reasonable accommodation for any part of the application or interview process please click on the link here and let us know the nature of your request along with your contact information.
Recruitment Fraud Notice
Baxter has discovered incidents of employment scams where fraudulent parties pose as Baxter employees recruiters or other agents and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself review our Recruitment Fraud Notice.
Required Experience:
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About Company
Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected ... View more
