Senior QARA Specialist
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Job Location:
Monthly Salary:
Posted on:
16 hours 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.
- Responsible for QA and RA communications with health authorities
- Will be the nominated pharmacist in charge for Baxters operating establishment will be the authorized signatory entity & official responsible pharmacist for all PVQARA communications.
- Will be nominated as Baxters point of contact for all RA & QA activities in front of MOH.
- Assume the tasks of the Responsible Pharmacist of Baxter entity in Algeria as defined by the local regulations.
- Ensure company compliance with applicable Acts and regulations and cGMP in the control of medicines and medical devices distributed and sold by Baxter Healthcare.
- Prepare for MOH audits and ensure satisfactory outcomes.
- To keep awareness and being updated on relevant national Algerian and assigned countries legislation and inform ECEMEA cluster head and global teams about any relevant changes to the legislation.
- To ensure 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 Baxter 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.
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:
Senior IC
Key Skills
- Computer Hardware
- Mac Os
- Manufacturing & Controls
- Root cause Analysis
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- Cerner
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
