QA Manufacturing Operational Specialist

☞ Ferring Pharmaceuticals, Inc.

Aussicht: 136

Update Tag: 08-04-2024

Ort: Saint-Prex Vaud VD

Kategorie: Beratung / Kundenservice

Industrie:

Jobtyp: 100%, Temps de travail : 90-100%

Loading ...

Jobinhalt

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.
Our Technical Operations division develops, manufactures and supplies high-quality products so our patients can live better lives. Creating and delivering life-changing products means getting it right first time is a shared responsibility, so our global manufacturing teams work closely together to ensure quality, accuracy and safety at all times. That means a culture of empowerment, where speaking up is valued, and growth and development are constant.
Ferring+You
You will ensure that batch records are reviewed in a timely manner according to all SOPs, carry out Quality reports investigations and closure, in order batches could be released in conformity with the registration dossier and cGMPs.
As Confirmation / certification Officer you will perform, according to applicable flows:
  • the bulk product [and/or] intermediate product confirmation, based on previous confirmation(s), if applicable
  • the product confirmation [and/or] the finished product certification, based on previous confirmation(s) if applicable [and/or] the authorization for finished product transfer to saleable stock.
Your day at Ferring
  • Ensure GMP compliance for QC/production/maintenance activities
  • Manage, evaluate deviations on batch product, and drive investigations plan and corrective action. Decide about batches affected by deviation when appropriate.
  • Handle finished product drug complaints related to defect related to the manufacturing process, customer observation.
  • Write APR (Annual Product review) / PQR (Product quality review) according to annual Master plan defined
  • Confirm intermediate product or bulk product. Confirm product [and/or] certify finished product based on previous confirmation, if applicable, [and/or] authorise product transfer to saleable stock
  • Check that all investigations pertaining to the batch being confirmed and/or certified (including out of specification and out of trend investigations) have been completed to a sufficient level to support confirmation, with, if required, escalation to QA operational manager [and/or] RP (QP), according to internal SOP
  • Verify that all quality control (QC) test data (including IPC) complies with the product specification described in the MA
  • Verify all manufacturing steps had been made in compliance with applicable GMP and MA
  • Ensure that all supply chain flows from API, excipients and packaging materials production sites to the confirmation [and/or] certification are available and under control
  • Check that any impact of any change to product manufacturing or testing has been evaluated and any additional checks and tests are complete
  • Technical know-how of: Product processing (solid form), Quality control (analytical, and microbiological), Outsourced manufacture management activities, EUGMP Annex 16
Behind our innovation…There’s you
  • Diploma or a degree from higher studies such as university or equivalent in the area of nature science
  • At least 3 years in a company with authorization manufacturing, performing qualitative and quantitative analysis of API and other tests for quality specifications
  • Knowledge of manufacturing, importation, market release of pharmaceutical product and GMP
  • Good communication and interpersonal skills
  • Problem solving mindset
  • Team spirit, flexible and proactive
  • Customer and result-oriented
  • Ability to take decisions and work independently
People come first at Ferring
  • 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
  • Parental leave for both birthing and non-birthing parents
  • Extended support on family building journey
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:
Switzerland SMP - St Prex
Loading ...
Loading ...

Frist: 23-05-2024

Klicken Sie hier, um sich für einen kostenlosen Kandidaten zu bewerben

Anwenden

Job melden
Loading ...
Loading ...

ÄHNLICHE ARBEITEN

Loading ...
Loading ...