Quality Assurance Associate

Posted 11 Days Ago
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Manila, First District NCR, National Capital Region
Mid level
Pharmaceutical • Manufacturing
The Role
The Quality Assurance Associate ensures compliance with GMP and GDP regulations across company operations and ensures that products meet specifications. This role involves managing quality complaints, implementing QMS, conducting audits, and training affiliate staff on quality standards.
Summary Generated by Built In

Galderma is the emerging pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body's largest organ - the skin - meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin, we are in shapes our lives, we are advancing dermatology for every skin story.

 

We look for people who focus on getting results, embrace learning and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration. Above all, they must be passionate about doing something meaningful for consumers, patients, and the healthcare professionals we serve every day. We aim to empower each employee and promote their personal growth while ensuring business needs are met now and into the future. Across our company, we embrace diversity and respect the dignity, privacy, and personal rights of every employee.

 

At Galderma, we actively give our teams reasons to believe in our bold ambition to become the leading dermatology company in the world. With us, you have the ultimate opportunity to gain new and challenging work experiences and create an unparalleled, direct impact.

Responsibilities :

  • Serves as the GMP and GDP responsible person ensuring that the Quality Management System and the operations comply with the national, regional and international regulation requirements

  • Ensures that the QA requirements and Galderma standards and procedures are followed throughout the company operations

  • Ensures all locally and internationally manufactured products meets the required specification set by Galderma

  • Ensures GMP and GDP requirements are complied by 3rd party manufacturer’s and local service providers

  • Ensures compliance of all packaging materials before and after printing

  • Management of local quality complaints as per local regulations and procedures

  • Performs quality-specific tasks including but not limited to processing product complaints, deviation, CAPA, audits, change control, management reviews and product recall

  • Ensure affiliate 3rd parties are qualified, maintained in approved status and quality agreements established.

  • Implementing and maintaining the QMS to ensure that required SOPs are established.

  • Support principal release of products received inbound.

  • Authorization of product from quarantine to approve status, disposition for trade returns and damaged products.

  • Maintenance, analysis and reporting of Quality KPIs

  • Ensure local repackaging of products is performed in accordance with specifications and required licenses.

  • Conduct induction and refresher training related to QMS for local affiliate staff

Requirement :

  • Bachelor degree and/or above major in life sciences related required or registered pharmacist

  • Minimum 3 – 5 years Quality Assurance experience in pharmaceutical and medical devices and/or cosmetic industry 

  • Good knowledge and understanding of GMP and GDP regulations, guidelines and policies governing the healthcare industry (pharmaceutical, cosmetic, medical device)

  • Working experience with regulatory compliance inspections

  • Good working relationship with among cross functional teams

  • Experience working in an international matrix organisation

  • Experience as quality auditor would be beneficial

  • Experience in Quality internal and/or external 3rd party vendor audits

The Company
HQ: Dallas, TX
5,930 Employees
On-site Workplace

What We Do

Galderma is the leading company solely dedicated to skin and advancing the future of dermatology.
We deliver an innovative, science-based portfolio of sophisticated brands and services across Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Through trusted partnerships with healthcare professionals, we ensure to meet individual consumer and patient needs with superior outcomes.

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