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Quality Assurance (QA) GMP Compliance Expert
Quality Assurance (QA) GMP Compliance Expert
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Quality Assurance (QA)
Compliance Expert in Pharma
Location: Zurich / Zug
Role: Consultant, Subject Matter Expert
Role & Responsibilities
In your role as a Consultys Compliance expert, you are supporting our clients and project teams by:
Harmonization of (Global) Quality Management Systems
Gap Analyses of the Q-Manuals against relevant Guidelines and Regulations
Developing and implementing QMS (Policies/SOPs) improvements of our clients
Review and correction of SOP landscapes
Writing of Global Quality Standards
Ensure complied documentation systems of our clients
Writing Quality risk management (QRM) concepts with the corresponding SOPs, templates and tools
Conception and Implementation of Supplier Quality Agreements
Handling of Change Control Requests, Non-Conformities and CAPAs, ensuring their adequate and timely closure from QA perspective
Supplier and Internal Audits including Mock-Inspections
Planning and moderation of QA workshops and training events
Support tech transfer and analytical method transfer activities
University degree in Quality, Engineering, Sciences or another relevant discipline
At least 2-3 years of experience within a GMP-regulated environment, preferably in the Pharmaceutical or Medical Devices industry
Broad working knowledge of Quality Management Systems, cGMP and ICH Q9 regulations; basic understanding of manufacturing and supplier process
Analytical and structured working style; strong attention to detail
Ability to effectively work as part of a multidisciplinary, international team
Fluency in English is required, German, French or Italian would be a plus
Hands-on personality, with flexibility and dedication to maximize our client`s value
At a glance - Working as a Consultys Compliance Expert
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. 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.