Qualification / Validation Compliance Engineer
Qualification / Validation Compliance Engineer
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Qualification / Validation Compliance
Location: Zurich / Zug
Role: Consultant, Subject Matter Expert
Role & Responsibilities
The Qualification and Validation Compliance Engineer will support our Pharmaceutical client and conduct validation studies, technology transfer activities, process characterization studies and gauge R&R studies within the Manufacturing Process. This position will also provide guidance on the equipment/process validation requirements and design control activities for new product development projects.
Support/conduct FAT/SAT and then IQ/OQ/PQ validation studies of equipment and processes, utilities and software validations
Advise project teams, develop/review and approve validation protocols and final reports
Manage Change Control on material specifications and documentation, develop and validate test method validation
Support of continuous improvement on process, and on Qualification and Validations project
Maintain equipment to support GMP manufacturing ensuring all equipment complies with Standard Operating Procedures and Policies
Participate in project planning, scheduling, and tracking
Develop and implement procedures to comply with corporate and industry standards
Provide internal and external trainings
University degree in Engineering, Chemistry or another relevant discipline
At least 2-3 years of experience in Qualification and Validation activities and/or projects
Applied knowledge of SwissMedic and FDA and international Pharmaceutical regulations
Applied technical understanding of manufacturing equipment; processes specific to Pharmaceutical manufacturing preferred
Applied Knowledge of creation and verification of qualification equipment plans (FAT/SAT/DQ/IQ/OQ/PQ)
Analytical and structured working style; strong attention to detail
Ability to effectively work as part of a multidisciplinary, international team
Hands-on personality, with flexibility and dedication to maximize our client`s value
Fluency in English is required, German, French or Italian would be a plus
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.