GxP and Medical Device Compliance Services
 


QA Expert - Clinical Supplies and Packaging

Location:   Zurich / Zug
Country:    Switzerland
Role:           Consultant, Subject Matter Expert
Team:         Pharma/Biotech
 

Role & Responsibilities

  • Review of batch documents for label release of API, Safety Assessment or clinical supply lots (bulk and packaged) to ensure conformance to appropriate regulatory requirements

  • GMP review of batch documents and disposition of Clinical Batches for use in clinical trials 

  • Deviation and change handling for packaging, lab investigations and related records

  • Act as contact person for complaints and temperature excursions

  • Ensure quality and compliance of all qualifications documents

  • On behalf of Manager Quality Systems, review and approval of specifications for clinical use and of method validation summaries

  • Preparation and implementation of procedures related core tasks

  • Responsible for metrics related equipment qualification

  • Issue reports summarizing deficiencies and work with areas to execute remedial action

  • Communicate and resolve audit comments with client areas

  • Under supervision, or as part of a team, perform audits or inspections of assigned areas or systems to assess compliance with regulatory and Company standards

  • Review and approval of SOPs
     

Position Requirements

  • University degree in Quality, Engineering, Sciences or another relevant discipline

  • At least 1-3 years of experience within a GMP-regulated environment, preferably in the Pharmaceutical or Medical Devices industry

  • Broad working knowledge of cGMP regulations; basic understanding of manufacturing process

  • Analytical and structured working style; strong attention to detail

  • Ability to effectively work as part of a multidisciplinary, international team

  • Good verbal and written communication skills in English, German language is a plus

 

At a glance - Working as a Consultys Compliance Expert
 

Prismond Group - At a glance
Consultys Group

Consultys is a LifeScience service company with diverse career opportunities. We link operational compliance, quality assurance, regulatory and own solutions in ways that master complex compliance challenges to help our Pharma, Medical Devices and BioTech clients in the regulated environment.
Prismond Group - Boost our career
Boost your career

A consultant position with Consultys boosts your career, as you benefit from interesting, hands-on compliance projects, internal and external trainings, 1:1 mentoring and the expertise of our passionate experts.
Perks and Benefits

Consultys offers a wide range of benefits and opportunities for your professional development. Flat hierarchies, consulting with a partnership approach and a close-knit family atmosphere are essential elements of our company culture. Whether you join us as an intern, a recent graduate or a senior hire, Consultys offers great perks and benefits.

Take Action - Apply Now.


Please submit your online application in English or German language.

For further information, please contact our local Human Resources department.

F.A.Q. for Applicants

At Consultys we want to make it easy for you to find and apply for a job, which is why we have listed here the most commonly
asked questions we receive regulary.

Is Consultys a headhunter / agency company? . . .

No, Consultys is neither headhunter nor a job agency. We are providing our clients local, operational, compliances services within an integrated team-approach. Consultys always owns the direct relationships to the responsible line manager(s) within the organization.

In which countries Consultys is offering it`s services? . . .

We offering our compliance services for LifeScience clients mainly in Switzerland, Germany, France and Belgium, locally.
In addition we are offering our Medical Device clients dedicated services in Product Certification and Mock-Inspections for the US market (FDA).

What is the typical size of Consultys clients? . . .

Consultys offers it`s compliance services, tools and solutions for LifeScience organizations of all sizes, from small start-ups, spin-offs (ETH, EPFL, …) to mid-size (KMU) and global companies with thousands of employees.

You submitted your application. What is the usual timeframe you should hear from us? . . .

Once you apply to the position, you will be provided with an automatic email confirming that your application has been successful. Timeframes differ by team but you should expect an answer within a few weeks, usually this will be faster. Once you have applied for the first time, your profile will be stored in the system. You might be contacted by our recruiters or by our automatic matching tool of job opportunities of interest to you.

In any case, your resume/CV will remain in our database for up to 4 years and we might contact you during that time. If you would like to be removed from the database, please review the FAQ "How can I delete my profile from the Consultys Talent Pool listed below.

What does the typical recruitment procedure look like? . . .

When applying for a position, your information will be made available to our recruiters. They will analyse your skills & experience and will compare it to the requirements of the position for which you have applied (as well as any other open position).

If we believe you match the requirements, we will contact you and, in a first phase, we will invite you for a telephone interview or physical interview (or videoconference interview); further interviews will be fixed when evaluated positively.