senior Quality ManagerBaxter

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.
Location: Canlubang Plant, Philippines
Job Scope: Develop and deploys the quality system for the Canlubang Plant. Assures systems and procedures for regulatory compliance are established and deployed. Management representative for the Canlubang plant quality system and periodically reviews the suitability and effectiveness of the quality system with executive management.
Reporting to APAC Director in Singapore
Dotted Line to Plant Manager in Canlubang
Job Details:
Providing adequate supervision for the testing, approving or rejecting components, containers, closures, in-process materials, packaging material, labeling, and final products
Ensuring the maintaining the GMP compliance status per the applicable regulations and relevant GMP activities
Providing guidance and resources to ensure that Baxter employees are aware of current applicable regulations, standards, and Baxter/customer requirements and understand the criticality of complying to them
Reviewing production/quality records to ensure that exceptions have been appropriately addressed
Approving or rejecting procedures or specifications impacting the quality and performance of the product
Initiating the Field Actions process and approving the final Field Action decision
Ensuring that regulated activities, not directly managed by the quality unit, are controlled by appropriate quality processes
Elevating issues or concerns to higher level QMRs and/or MWERs for review.
Maintaining the Management Review process for the entity
Ensuring site compliance to applicable regulations and standards
Establishing and maintaining site certifications
Qualifications:
Bachelor of related Science or Pharmacy (Preferrable Pharmacist License)
Background in Quality Management for Medical Devices or Pharmaceutical Manufacturer.
At least 8 years in Quality Assurance, Quality Control, Regulatory Affairs and related.
Well knowledgeable in PIC/S Regulation and working with Ministry of Health.
Excellent in English communication skills in both, written and verbal.
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 [Protected Info] and let us know the nature of your request along with your contact information.
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Baxter

Calamba City, Laguna
Permanent
Full-time