QA Packaging Operations Specialist
Veröffentlicht:
29 November 2024Pensum:
100%- Arbeitsort:Switzerland SMP - St Prex
Job Description:
At Ferring Pharmaceuticals, we help people around the world build families and live better lifes. 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 procedures; carry out quality reports investigations and closure in order batches could be released in conformity with the registration file and cGMPs.
You will perform 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
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Ensure GMP compliance for production/maintenance activities
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Manage, evaluate deviations on batch product, and drive/lead investigations plan and correctives actions. Decide about batches affected by deviation when appropriate
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Check that all investigations pertaining to the batch have been completed to a sufficient level to support confirmation or certification, with, if required, escalation to QA operational manager [and/or] RP (QP), according to internal SOPs
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As an operational QA, you will be on the production areas to provide the necessary support for production in order to guarantee and verify all packaging steps had been made in compliance with applicable GMP and MA
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Follow up CAPA and change for production activities
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Approve master batch records, master data and packaging instruction according to internal SOP
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Handle finished product drug complaints related to defect related to the packaging process, customer observation
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Write APR (Annual Product review) / PQR (Product quality review) according to annual Master plan defined
Behind our innovation…There’s you
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Scientific background:
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Min. 3-5 years’ experience in the pharmaceutical industry.
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Confirmed experience in QA release activities
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Good communication in French and English
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Strong understanding of cGMPs
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Good knowledge in Regulatory requirements
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Knowledge market release of pharmaceutical product and GMP
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Soft skills:
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Good communication and interpersonal skills
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Problem solving mindset and Lean approach
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Team spirit, flexible and proactive
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Customer and result-oriented
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Ability to take decisions and work independently
People come first at Ferring
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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
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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
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Parental leave for both birthing and non-birthing parents
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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.