Beschreibung
Randstad Professionals is looking for a QA Project Manager for their client in Basel
Purpose of Job:
The Quality Project Manager position will provide in-depth Quality expertise for the company products and drug delivery systems under development to ensure compliance with Quality Systems Regulations, Medical Device Directives and company standards. The position will serve as the Quality single point of contact for the Device Development project.
Responsibilities:
- Serve as the Quality Single Point of Contact for allocated Device Development project and ensure all projects follow the applicable risk management procedures, Design Control activities, Design History File and prepare Control Strategy definition. In that respect, he/she will have to actively participate in project Core Team in which he/she will also assess quality and compliance with the regulations for Clinical.
- Collaborate with all QA representatives (Clinical Quality, Supplier Quality,QA validation to ensure Quality Robustness of the interface between the Drug Product and the Component of the Device forming the Combination Product, up to the Control Strategy.
- Animate the quality sub-team for the Combination product, as appropriate.
- Create and deploy Risk Management Plan/Report, actively participate up to facilitating FMEAs, define Delivery System specifications accordingly including Drug Product/Component interface), and ensure all necessary release GMP documentation are completed and in place from Incoming to release of Combination Product at the manufacturing internal Site and/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. Drive change control as change controller. Represent department at Quality Review at the Board and Change Review Board meetings.
- Lead and/or actively participate in workstreams for improvement of all quality engineering activities and practices either on a local basis or at platform level. Actively propose new approaches to robustness.
- Support regulatory inspections, company compliance audits and regulatory filings (ie, review and provide input to filing documentation)
- Recommend and implement improvements to Quality operational policies, plans and procedures. Act as an integral member of process improvement teams and process roll outs.
Requirements:
- BS degree in Life Sciences discipline or Chemical/mechanical engineering, Graduate degree preferred
- Hands on expertise in device manufacturing and knowledge of aseptic manufacturing 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, 21CFR part 4 and 820
- Travel required is approximately 10 - 20%
- English speaking - German is a real plus