About the role
The QA specialist is responsible for maintaining and improving the quality management system, including GMP and ISO compliance. They also manage internal and external audits, supplier assessments, and provide quality-related training.
What they look for
Requirements
Candidates must hold a bachelor's degree or higher in a relevant engineering or pharmaceutical field. A minimum of 3 years of QA experience in the pharmaceutical industry is required.
Full description
Roquette is a family-owned global leader in plant-based ingredients and a leading provider of pharmaceutical excipients.
Want to help us make a difference? Using plant-based resources, we collaborate with our customers and partners to imagine and offer ingredients to better feed people and treat patients. Each of our ingredients responds to unique and essential needs, and they enable healthier lifestyles.
Key Responsibilities:
1) To be responsible for establishing, maintaining and continuously improving the quality management system and ensuring its effective operation (GMP, ISO9001, ISO22000/FSSC22000);
2) To be responsible for external and internal training related to quality department, including preparation of materials, organization of training, confirmation of training effects, etc., including but not limited to GMP, HACCP, ISO;
3) To be responsible for the preparation and updating of raw materials and product quality standards;
4) To be responsible for the collection and updating of foreign documents related to company's products, quality and food safety, such as laws and regulations, national standards, etc.
5) To participate in the assessment and demonstration of the quality management of new and old suppliers;
6) To be responsible for the follow-up, confirmation and closure of the action plans issued by non-conformities in internal audits, external audits, and customer audits;
7) To assist quality evaluators in the daily work of evaluating the quality of products and related raw materials
8) To assist superiors in analyzing, processing and resolving customer quality issues, satisfy internal and external customer quality requirements, and continuously improve product quality satisfaction;
9) To assist the superior to complete each external audit, including government, customers, and third parties;
10) To be responsible for the product quality reviews.
11) To be responsible for the pest control.
Qualifications:
1. Bachelor’s degree or above in Pharmaceutical Engineering, Pharmacy, Pharmaceutics, Bioengineering, Chemical Engineering, or related fields.
2. Minimum 3 years of QA experience in the pharmaceutical industry; experience in pharmaceutical facility construction/validation is preferred.
3. Excellent communication, coordination, and teamwork skills.
4. Good English reading and writing skills; proficient in Microsoft Office Suite.
If you identify yourself in this position, please apply by uploading your resume and let's start the journey together!
Roquette is proud to be a global company where you can find personal and professional growth through multiple diverse experiences.
Roquette strives to create a dynamic workforce while remaining firmly committed to equal opportunity by complying with EEO laws.
As we continue to grow, Roquette understands that to be successful we must always be inclusive in our approach.
To find out more about our products, values and sustainable development ambitions visit us at www.roquette.com and at www.sustainability.roquette.com
Similar roles
-
Intern - Engineering (QA)
Coherent Corp. Singapore, Singapore
-
Supervisor QA Mecánico
SGS Paucarpata, Arequipa, Peru
-
Supervisor QA Eléctrico
SGS Paucarpata, Arequipa, Peru
-
QA Analyst
Golden Agri-Resources (GAR) Dumai City, Riau, Indonesia
-
QA Automação - Sênior
Jobgether Brazil
-
Senior QA Automation Engineer
Netsmart Bengaluru, Karnataka, India