Senior QA Specialist at Ferring Pharmaceuticals

Hvidovre Municipality, Capital Region of Denmark, Denmark -

Full Time

Start Date

Immediate

Expiry Date

01 Feb, 26

Salary

0.0

Posted On

03 Nov, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Assurance, Supplier Management, GMP, Documentation Management, Collaboration, Communication, Auditing, Regulatory Compliance, Deviation Assessment, CAPA, SOPs, Quality Control, Technical Agreements, Problem Solving, Inspection Readiness, Pharmaceutical Industry Knowledge

Industry

Pharmaceutical Manufacturing

Description

Job Description: Senior QA Specialist for QA Support team Are you looking to make a meaningful impact and drive quality excellence in a dynamic environment? Do you want to be responsible for qualifying new suppliers and upgrading compliance to support the robust production of a high-quality API? Then we encourage you to apply and join our dedicated Syntese team. You will play a crucial role in our supplier management qualification, support to QC and general compliance activities in partnership with colleagues in Procurement, Operations, QC and across the Ferring Pharmaceuticals network. “You’ll have a lot of freedom to impact our supplier management processes, and if you’re anything like me, you’ll really enjoy seeing the effects of your work in the organization,” says Birgit Hansen, a fellow QA Specialist and your closest colleague. Ferring + you Syntese is a part of the Ferring Pharmaceuticals global matrix. We are renowned worldwide for our reliable production of high-quality Mesalazine, an Active Pharmaceutical Ingredient (API) used in treating inflammatory bowel diseases. At our manufacturing site in Hvidovre, you will join the quality division, which is responsible for quality control, quality assurance, and regulatory affairs. Specifically, you will be part of our QA/RA Support team, where you will work with 4 QA/ RA Specialists and report directly to the Head of Quality. Your day at Ferring Your initial focus will be on qualifying new suppliers, and you will be responsible for ensuring that our supplier management activities meet regulatory and industry standards. This includes approval, audit, Quality technical agreements, and periodic evaluation of the suppliers. You will also offer general quality and compliance support to QC, Production, Engineering, and our warehouse, including assessment of deviations, OOS investigation, CAPAs, changes, SOPs, etc. More specifically, your primary responsibilities will include: performing supplier qualifications and evaluations preparing quality technical agreements support to QC and approval of QC related documentation planning, performing, and documenting supplier audits implementing quality activities and compliance upgrades within the QA/RA Support team representing Syntese during authority inspections, partner inspections, and inspections conducted by Ferring Global Quality Technical Operations. You will also have the opportunity to participate in global networks, as you support the implementation of quality standards within supplier management in alignment with Ferring’s global quality initiatives. Behind our innovation – there’s you To thrive in this role, you will need excellent collaboration and communication skills, enabling you to navigate complex situations and processes effectively, and you are comfortable making decisions in a dynamic environment. Additionally, you: have several years of QA experience in the pharmaceutical industry have a strong understanding of GMP, especially in relation to supplier management and QC preferable you are a certified lead auditor or have experience with supplier management are comfortable managing documentation in systems such as TrackWise and Veeva can communicate respectfully and confidently in English. People come first at Ferring At Syntese, we value initiative and empower our team members to drive positive change. Joining us, you will experience great space for execution, influence, and the opportunity to work independently. Your potential impact on the organization will be high, as our empowering culture entails very short decision paths. We work well together because we all contribute value by doing precisely what each of us does best, giving us high job satisfaction. Behind our purpose – there’s you If our mission and your vision are aligned, please apply. Kindly include a few lines regarding your motivation for applying in the CV or a cover letter. Please note that we review applications continuously and close the process when we find the right match. For any questions about the role, please reach out to Linda Juul Schæffer, Quality Site Head, on +45 21121716. If you have questions about the recruitment process, please contact Talent Acquisition Partner Mette Markussen at mette.markussen@ferring.com. We are unable to offer relocation assistance for this position. Candidates must be located in the Oresund region or be willing to relocate at their own expense. Note to agencies: This search is being managed by Ferring’s Talent Acquisition team. Kindly do not send us unsolicited profiles. About Syntese Syntese A/S is a Danish pharmaceutical company owned by Ferring Pharmaceuticals, a research-driven, specialty biopharmaceutical leader in reproductive medicine and maternal health and in specialty areas within gastroenterology and urology. Syntese was founded in the early 1980s when a Ferring Group team in the Synthesis department invented the 5-ASA purification process that was to become the cornerstone of their business. Today, Syntese manufactures Mesalazine, an active pharmaceutical ingredient (API) used to treat inflammatory bowel diseases. Syntese is renowned worldwide for stable Mesalazine of exceptional quality. The company has been growing steadily during its lifespan and is now among the world’s biggest manufacturers of Mesalazine – and still the only company that is dedicated only to Mesalazine. Syntese’s Mesalazine is registered in more than 100 countries, including the EU, the US, Canada, Japan and Australia. Location: Denmark API Production (Syntese) Ferring Pharmaceuticals a privately owned, research-driven, specialty biopharmaceutical group committed to building families and helping people live better lives. We are leaders in reproductive medicine with a strong heritage in gastroenterology and urology, and are at the forefront of innovation in uro-oncology gene therapy. Ferring was founded in 1950 and employs more than 7,000 people worldwide. The company is headquartered in Saint-Prex, Switzerland, and has operating subsidiaries in more than 50 countries which market its medicines in over 100 countries. Learn more at www.ferring.com, or connect with us on LinkedIn, Instagram, YouTube, Facebook and X. At Ferring, we'll give you the tools to shape a career build on purpose. Join us and help People around the world to build families and live better lives. Click HERE to enlarge the picture. Click HERE to learn more about this award. At Ferring, our focus on Patient Advocacy drives our commitment to create more equitable health outcomes for all, at every stage of their healthcare journey. We believe in everyone’s right to access the best treatment, pioneering into new therapeutic areas, and developing innovative ways to diagnose, treat and prevent diseases. Don't see the dream job you are looking for? Drop off your contact information and resume and we will reach out to you if we find the perfect fit!

Responsibilities

You will be responsible for qualifying new suppliers and ensuring that supplier management activities meet regulatory and industry standards. This includes performing supplier qualifications, audits, and providing quality support to various departments.