- Writing GDP related SOP's and manage the administration of GDP documentation and records.
- Ensuring adequate processes and procedures are in place to facilitate the verification of medical products and any other requirements that may impact GDP activities.
- Assisting in the approval of suppliers, customers and third parties' activities related to the distribution of our products.
- Managing and optimizing technical agreements between FPBV and third-party customers.
- Managing Ferring's Distribution Centers at a regional and a global level.
- Performing quality assessment of deviations derived from storage and transportation processes and ensuring effective corrections and CAPA's are well established and implemented.
- Monitoring quality mailboxes and QMS's for releases and follow-up with relevant departments.
- Performing quality audits regarding Logistic Service Providers and third-party customers as per compliance and business needs.
- Acting as "Responsible Person Delegate" for FPBV.
- In the role of Responsible Person Delegate, decide on the final disposition regarding returned, rejected, and falsified medical products, including any decision on returning to saleable stock.
- Supporting the continuous improvement of the QMS.
- University Degree in Pharmacy, Chemistry or Biology.
- 7 years of experience as a QA Manager and/or Responsible Person (Delegate) in the Pharmaceutical Industry.
- Sound knowledge and experience in Quality Assurance and Regulatory Inspections.
- Good ability to work with Quality Management Systems.
- Experience managing Pharmaceutical distributors and in the EU distribution compliance guidelines.
- Strong experience in GDP inspections and audits.
- Excellent proficiency in English. Spanish is an advantage.
- Good communication skills and cultural awareness.
- Experience in Project Management.
- Able to multitask, organize and prioritize under time constraints.
- Strong team player skills and the ability to work and thrive in a complex matrix environment.
- Get inspired from our commitment to advocate for everyone's right to build a family, no matter who you are, where you live or who you love.
- Our inclusive support package – "Building Families at Ferring" provides equal and accessible policies for all employees who wish to start their family journey, ensuring a global standard, irrespective of location and role. Available to all employees after the first year of employment.
- Parental leave for both birthing and non-birthing parents.
- Extended support on family building journey.
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Quality Assurance Manager - Hoofddorp, Nederland - Ferring Pharmaceuticals
Beschrijving
Job Description:
At Ferring Pharmaceuticals, we help people around the world build families and live better lives. We are entrepreneurial and innovative, with a global team focused on scientific advances in the areas of reproductive and women's health, gastroenterology, and urology. Ferring + You is all about working together and sharing ideas, so that we can bring science to life for patients around the world.
Every person at Ferring works together to change lives and help people build families. Our corporate teams offer empowering, innovative, challenging and rewarding careers – we are motivated to make a difference. To reach our full potential we collaborate, and respect and value diverse contributions so that we can grow as an organization and as professionals. Together we can influence the world around us to make life and work better.
We are looking for a QA Manager to work in the QA department of our Global Trading Entity, Ferring Pharmaceuticals BV (FPBV). The QA department of FPBV ensures compliance with the EU Good Distribution Practices (GDP) guidelines, maintaining our Wholesaler Distribution Authorization (WDA) and our Quality Management System (QMS) updated.
Ferring+You
In this position, you will be responsible for maintaining FPBV Distribution Quality Systems, ensure inspection readiness at all times and provide adequate and timely responses to observations and follow-up on CAPA implementation.
You will assist Health Authority inspections at FPBV and distribution centers and support GXP surveillance and assessment of new regulations where appropriate and required.
We also expect that you act as "Responsible Person Delegate" for FPBV. Furthermore, you will be responsible for performing post-certification disposition of batches to be released, quarantined, or rejected upon instruction from Global QA teams or releasing sites.
Your day at Ferring
Behind our innovation...There's you
People come first at Ferring
Making a difference in the life of millions of people means we succeed by working together. Our diverse backgrounds, experiences, expertise, and perspectives enable us to find solutions to even the most challenging problems, and our success is tied to each team member's contributions. Imagine the power of your career when it's Ferring + You.
Behind our purpose... There's you
If our mission and your vision are aligned, please apply
We strive to build and maintain an inclusive and diverse workplace with equal opportunities and mutual respect for all employees regardless of their backgrounds and socioeconomic status.
Location:
Ferring B.V. Holding
