Scientist, Device and Product Performance (18 month fixed-term contract)

Viatris Inc.; Dublin; On-site; EUR 40,000 - 60,000; Full time

Job summary

A global healthcare company in Dublin is seeking a candidate for a pharmaceutical role focusing on product development and regulation compliance. Responsibilities include collaborating with affiliates for registration batches and compiling technical documentation. Ideal applicants are motivated and skilled in communication, with a background in pharmaceutical or medical device development. Competitive salary and benefits are offered in an inclusive work environment.

Benefits

Competitive salary

Benefits

Inclusive environment

Qualifications

• Experience of writing and supporting regulatory submissions would be an advantage.
• Able to communicate technical and/or project information to key stakeholders.
• Some travel will be required as part of this role.

Responsibilities

• Dealing with Viatris Affiliates and/or Third Partner Companies to support exhibit and registration batches.
• Responsible for compilation and review of technical documentation within GDD.
• Support of all R&D Lab activities including Equipment calibration and Qualification.

Skills

Proven experience in pharmaceutical and/or medical device development

Experience in the development and validation of analytical methods

Working knowledge of design control requirements

Highly driven and motivated

Well-developed communication skills

Job description

Key responsibilities for this role include:Dealing with Viatris Affiliates and/or Third Partner Companies to support exhibit and registration batches, through review and implementation of controls and additional requirements if needed such as manufacturing investigations. Ensuring that the Combination Product meets any requirements for reliability, through implementation of appropriate controls and assessment of the product against suitable specifications. Responsible for compilation and review of technical documentation within GDD in line with global regulatory requirements, guidance’s and the latest regulatory and industry thinking. Support of all R&D Lab activities including, Equipment calibration and Qualification, Documentation requirements, Trackwise records.Attending EHS training and maintaining responsibility for adhering to appropriate EHS procedures. Ensure the appropriate risk assessments are in place to perform required tasks. Support equipment qualifications, vendor calibrations and preventative maintenance in line with the laboratory qualification and preventative maintenance schedule as required.The minimum qualifications for this role are: Proven experience in pharmaceutical and/or medical device developmentExperience in the development and validation of analytical methods Working knowledge of design control requirements in line with FDA 21 CFR part 820 and ISO 13485 would be an advantage Experience of writing and supporting regulatory submissions would be an advantage Highly driven and motivated person who can work as part of a flexible, dynamic team whilst taking responsibility for individual tasks Well-developed communication skills to lead or facilitate effective discussions. Able to communicate technical and/or project information to key stakeholders.Some travel will be required as part of this role.At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.