The Quality Assurance Specialist provides an effective and efficient quality assurance system that ensures the compliance with Good Manufacturing Practice to guarantee that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required product specification and the filed dossier.
You report to the QA/QC Manager and provide support to product management and all other relevant disciplines.
- To implement quality standards; identify and resolve problems; perform audits; define and measure KPI’s; implement changes.
- To edit or review the performance of risk analysis studies when deemed necessary: identify critical control points and preventive measures; establish critical limits, monitor procedures, corrective actions, and verify procedures.
- To validate quality processes by establishing product specifications and quality attributes; document evidence; determine operational and performance qualification; write, update and approve quality assurance procedures; documentation control; calibration plan and supplier qualification
- To ensures compliance to the filed dossier, and that the standard work procedures are followed.
- To Carry out investigations, proposals for actions, evaluations, reviews, approvals and follow-ups related to OOS, deviations, incidents, complaints, CAPAs, whatever their origin may be..
- To prepare quality documentation and reports by collecting, evaluating and summarizing information and trends including failed processes, stability studies, recalls, corrective actions, and re-validations
- To prepare trainings for all the staff
- To write, review and/or approve SOPs, working instructions, manufacturing guides and other documents
- To participate as an expert in the external audits received and the Inspections of the Regulatory Authorities.
- Bachelor’s Degree in Pharmacology, Pharmaceutical Sciences, Life Sciences or similar.
- At least 5-10 years of experience as a QA specialist in a Pharmaceutical Company.
- Experience regarding the execution of EUGMP audits of APIs or excipients.
- Very valuable previous experience in FDA Inspections
- Quality Orientation, in problem-solving and organization skills. Good sense of priorities, structured, results-oriented and efficient.
- Social skills regarding working in a team
- Good knowledge of Microsoft Word and Excel, SAP, LIMS will be appreciated
- Proficiency in English and Spanish.
What makes Corbion truly special is our talented global team of people, who are consciously dedicated to connecting the work we do together with the difference it makes in the lives of consumers, including our own friends and families. At Corbion, innovation is in our DNA; we explore, we discover, we create, and then we do it all over again, finding ever-better ways to help the world solve some of its most pressing challenges. When you come to Corbion, you will find that for us, sustainability is not simply a corporate program, it is at the very heart of our business, giving direction to our work, our investments and our creativity. We exist to preserve what matters.
As a company where day-to-day priorities and decisions are shaped by a shared purpose and vision, we enjoy a working environment energized by empowerment and opportunity. By joining Corbion, you can be part of :
- A culture open to great ideas wherever they come from, and where your work can make a real difference in the world
- An organization that values diversity of thought, background and experience
- A company ready to invest in you, helping you grow toward your personal ambitions
- A workplace that’s friendly and informal, while being focused and professional
- An international team small enough to stay agile, but large and talented enough to make an impact today, and for future generations
Corbion does not accept unsolicited resumes from individual recruiters or third party recruiting agencies in response to job postings. No fee will be paid to third parties who submit unsolicited candidates directly to hiring managers. All candidates must be submitted by approved Corbion vendors who have been expressly requested to make a submission by our Talent Acquisition team for a specific job opening. No placement fees will be paid to any firm unless such a request has been made by the Corbion Talent Acquisition team and such candidate was submitted to the Corbion Talent Acquisition Team.