About the job
About the job
This position is responsible for monitoring, inspecting, and proposing measures to correct or improve our final products and processes in order to meet established quality standards. Responsibilities include developing and implementing quality assurance policies, conducting tests and inspections, identifying production, process, or product issues and presenting solutions. This role also has responsibility for a variety of Quality Management (QMS) Processes and Software: such as Equipment Preventive Maintenance, Corrective and Preventative Action (CAPA) and internal employee trainings.
Duties & Responsibilities
- Develop quality standards for the organization’s raw materials, and finished products and design new, complex, or innovative measures, tests, sampling methods, and other procedures to ensure that these standards are met.
- Write and revise standard operating procedures to meet the organization’s quality requirements and standards.
- Report on weaknesses, ineffective procedures, policy exceptions and discrepancies and recommend appropriate corrective actions.
- Support and facilitate audits and regulatory inspections with the aim of achieving a continuous improvement of processes.
- Liaise with external vendors, contractors or suppliers to ensure that their products or services meet the organization's quality standards.
- Provide training on Quality Assurance to internal colleagues with the aim of ensuring that everyone in the organization knows how to act according to quality standards.
- Provide oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.
- Oversight of the validation masterplan and the QC equipment maintenance plan.
- Review Certificates of analysys generated in CMO and interanlly for Fagron Brands B&E
- Quality CMO management: qualification of the ingredients, qualification of the CMO, create quality agreement with CMO
- Review quality agreements with customers and comply with the communications of changes
- Support on technical transfer of Fagron Brands B&E business
- Work in CMO floor when first batches are manufactured and filled
- Create ‘Replacement in Kind’ reports for ingredients and components
- Review method of manufacture from CMO, for final approval
- Review technical documents and create technical files
- Prepares reports and/or necessary documentation (ex Corrective and Preventative Actions) and provides to applicable stakeholders, both internal and external.
- Management and facilitation of quality documentation system.
- Continuously inform oneself about the latest trends in Quality and keep one’s knowledge up to date in function of new developments with the aim of consolidating one’s credibility, by offering a service which is continuously based on up-to-date knowledge.
- Other duties as assigned.
- Be the ambassador of Fagron Family Rules, Values and Culture
Set yourself apart
- Bachelor's degree in a science or technical related field and 3+ years of work experience in Quality or regulated industry OR advanced degree with 1+ years of work experience in Quality or regulated industry
- Experience with eQMS and validated software
- GMP, GDP, GLP experience
- Clear and effective communication Skills.
- Detail oriented
- Ability to concentrate for extended periods of time and follow established safety and procedures.
- Pharmaceutical industry experience
- OTC industry experience
- Experience with FDA, DEA, or other federal or state regulatory bodies
- Working knowledge of 21CFR 210 & 211, 21CFR Part 11
- Document control system operations
- Supplier qualification experience
What’s on offer?
We offer a dynamic environment where talent and ambition can develop to its fullest. We have an open and informal organization culture, where individuals need to have strong motivation and ability to work independently. Fagron is a widely expanding, international, professional and ambitious pharmaceutical company with multiple growth opportunities. Job opportunity includes competitive salary, comprehensive benefits, performance package, and ability to be part of an international leader in an expanding industry.