Quality Validation Manager Combination Product and Device

Quality Validation Manager Combination Product and Device

Randstad Professionals are one of the leading recruitment companies in Switzerland and with a dedicated IT contracting team in Zurich. We are excited to help you in your search. We focus on finding the best contracts for the best contractors.

Currently we are looking for a Quality Validation Manager Combination Product and Device, for a minimum 12 month contract, to join our client's team in Basel.

The Quality Validation Manager position will provide in-depth Quality expertise for our client's products and drug delivery systems under development to ensure compliance with Quality Systems Regulations, Medical Device Directives and our client's standards. The position will be a key interface between the Device Development Team and the Manufacturing Unit and will serve as the Quality Subject Matter Expert for Process Validations according to 21 CRF Part 4.

Responsibilities:

For allocated Medical Device/Combination Product development project:

- Serve as the Subject Matter Expert for Design Transfer, Process Validation and pFMEA requirements according to 21CFR Part 4 of allocated Medical Devices/Combination Products
- Serve as the Quality Subject Matter Expert for allocated Device Development projects and ensure all projects follow the applicable risk management procedures (especially for process FMEA), relevant Design Control activities, and prepare Control Strategy definition. In that respect, he/she will have to actively participate in the project Core Team in which he/she will also assess quality and compliance with the regulations for clinical and commercial production
- Collaborate with all QA representatives (Device Quality, Clinical Quality, Manufacturing QA, QA validation at the manufacturing site ) to ensure robust process validations are in place
- Actively participate up to facilitating process FMEAs, and ensure all necessary GMP documentation are completed and in place for Combination Products at the manufacturing internal Site or Device CMO, as appropriate
- Actively participate in elaboration of all design Control document for the Quality area of expertise, including use of statistical techniques to elaborate sample sizes and acceptance criteria
- Ensure and drive quality resolution for investigations related to the delivery system, and assessment of change controls. Represent department at Quality Review Board and Change Review Board meetings

Qualifications:

- BS degree in Life Sciences discipline or Chemical/mechanical engineering, Graduate degree preferred
- Hands on expertise in process validation for combination products preferred
- Demonstrated capability of applying risk management concepts and tools, and deploying Design Control
- Understanding of the biotechnology industry and specifically combination products and working in a global environment preferred
- Sound knowledge of cGMPs and relevant international regulatory requirements
- Well developed teamwork and collaboration skills and ability to communicate clearly and professionally both verbally and in writing
- Demonstrated problem solving and decision making skills including hands on working experience with tools Six Sigma/DMAIC is preferred
- Sound knowledge of Quality Systems Regulations, and Medical Device Directives, ISO 13485:2003 and ISO 14971 as well as 21 Part 210/211
- German and English speaking

Whether this role is the right fit or you would like to see if there are others that do, our dedicated and expert team is looking forward to hearing from you.

Good to know you!