QC Specialist Validation

vor 2 Monaten


SaintPrex, Schweiz Ferring Pharmaceuticals Vollzeit

Job Description:

Ferring Pharmaceuticals is a research-driven, specialty biopharmaceutical group committed to building families and helping people live better lives. Headquartered in St-Prex, Switzerland, Ferring is a leader in reproductive medicine and maternal health, and in specialty areas within gastroenterology and urology.

Ferring’s philosophy of “people come first” is lived through every part of our business. Join the Ferring team to help create life-changing medicines that make birth, life and living possible. 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, control and supplies high-quality products so our patients can live better life. Creating and delivering life-changing products means getting it right first time with a shared responsibility, so our global manufacturing teams work closely together to ensure quality, accuracy, and safety at all times. That also means a culture of empowerment, where speaking up is valued, and growth and development are constant.

Ferring+You

You will be part of the team, a dynamic, positive spirit and close-knit group working on analytical validation and many continuous improvement and compliance projects in the QC Laboratory.

Your day at Ferring

Serve as Subject Matter Expert for Analytical Validation and define analytical strategies

Perform periodic reviews and analytical validations of chemical test methods

Write documentation related to analytical validation activities (gap assessment, protocols, reports, procedures, etc.)

Process statistical data and interpret results

Possibly carry out validation analyses

Work in collaboration with the Regulatory QA department on the drafting of regulatory documents; Handle deviation, CAPA and Change control according to applicable procedure

Update internal SOP

Behind our innovation…There’s you

Master’s degree in Chemistry, Pharmacy or CFC in Chemistry with at least 5 years’ experience in the Pharmaceutical industry;

3 to 5 years’ experience in Analytical Validation or method development;

Technical skills in analytical procedures, especially Spectrophotometry, HPLC, GC, titration;

Proven working knowledge of Pharmacopeias (Ph.Eur., USP, JP), GMP and ICH guidelines. Knowledge in Regulatory Affairs is a plus.

Language: French and English (fluent, speaking & writing);

IT: Excellent knowledge of Office 365 (Word, Excel), LIMS, Empower and Minitab;

Soft skills: ability to take initiatives and work independently while developing and maintaining effective communication with stakeholders without formal authority; ability to work in “project mode” and deal with changes; strategic thinking.

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