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QA Specialist (Clinical Supplies) 100% (a)

Remote: 
Full Remote
Contract: 
Fixed term
Experience: 
Mid-level (2-5 years)
Work from: 
Switzerland

Offer summary

Qualifications:

Bachelor's or Master's Degree in life sciences, Minimum of 2-years' experience in GMP environment, Experience in batch record review recommended, Excellent understanding of GMP and GDP, Proficiency with SAP, MS Word/Excel preferred.

Key responsabilities:

  • Review and release incoming label stock and clinical finished goods
  • Conduct logbook reviews and batch record evaluations
  • Collaborate with internal and external partners
  • Communicate batch related issues to management
  • Support Quality Walkdowns and audits for compliance
Michael page logo
Michael page Human Resources, Staffing & Recruiting Large https://www.page.com/
5001 - 10000 Employees
About Michael page
Welcome to the Michael Page global company profile. Michael Page has five decades of expertise in professional services recruitment. We were established in London in 1976, and over this period we've grown organically to become one of the best-known and most respected consultancies, with an office network spanning six continents. While size has its advantages, it doesn't define us - the nature of our organic growth means that each new office is integrated into the region that it serves. It also means that as an employer looking to hire, or as a candidate aiming to grow your career you have the best of both worlds; a team that understands the market and geography you operate in, plus the resources and expertise of an international network at your disposal. Our teams are broken down to focus on industry, assignment type, salary level and location, so your hiring requirements or job search will all be handled by a specialist who knows your sector inside-out. We are confident that our expertise can add value to your recruitment or job search process – get in touch to find out more.
See more Michael page offers

Job description

  • Internationally renowned pharma company|12 months contract with extension option

About Our Client

We are currently recruiting for our client, a leading international company active in the pharmaceutical sector, with modern offices in the canton of Lucerne, a QA Specialist 100% (d/f/m) in a temporary position starting asap for the next 12 months, with the option of extension or take-over. Candidates who can immediately are strongly preferred.

Hybrid work model.

Job Description

The Quality Specialist (d/f/m) ensures that every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements (for the Clinical Supplies Team). In this position the selected candidate will be responsible for the following task area:

  • Reviewing and releasing of incoming label stock, clinical finished goods, including review of the printed and applied label
  • Logbook reviews and GMP review of the batch record and review of the regulatory filings and the final release
  • Collaborating closely with internal functional areas (i.e. GMP Manufacturing & Packaging & Logistics, Comparator Planning, Clinical Quality, Clinical Research Associates, Central Complaint Handling Unit, Batch releasing Quality) and external partners (i.e. Contract Manufacturing Organizations)
  • Communicating batch related issues to management, EU Qualified Persons and the Swiss Responsible Person (FvP)
  • Supporting Quality Walkdowns, GEMBA walks and/or Walkthrough Audits of GMP areas/on the shop floor to sustain continuous improvements efforts, ensuring quality compliance and/or identifying potential area of improvements

The Successful Applicant

In order to be considered for the role, the selected candidate must have:

  • Bachelor's or Master's Degree in life sciences required, ideally in biotechnology, biology or pharmaceutical studies. Master's Degree in clinical research, clinical data or clinical analysis is also advantageous.
  • Minimum of 2-years' experience in GMP environment within the pharmaceutical or related industry
  • Experience in batch record review is strongly recommended
  • Excellent understanding of GMP and GDP
  • High sense of accuracy and very good time management skills
  • Professional and precise communication to local and global stakeholders in English; German is a big advantage
  • Proficiency with SAP and MS Word/Excel as well as Six Sigma tool is preferred
  • Willingness to drive issue-resolution

What's on Offer

Get your foot into a renowned company in the pharmaceutical industry and have a direct impact on the development of novel biopharmaceuticals.

Hybrid work model.

Contact: Kamila Fotiou

Quote job ref: JN-102024-6556399

Required profile

Experience

Level of experience: Mid-level (2-5 years)
Industry :
Human Resources, Staffing & Recruiting
Spoken language(s):
EnglishEnglishGerman
Check out the description to know which languages are mandatory.

Hard Skills

SAP CO

Other Skills

  • Problem Solving
  • Collaboration
  • Verbal Communication Skills
  • Microsoft Excel
  • Time Management
  • Microsoft Word
  • Detail Oriented
  • Quality Assurance
Are you interested?

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