The Quality Assurance Lead Specialist is a vital position in ensuring the quality of our products. We are looking for an individual with strong initiative and leadership skills to join our team on a 12-month contract basis.
Key Responsibilities:
* To work with key stakeholders to develop and execute a readiness plan that ensures all GMP aspects of the new facility/project are aligned, functional, and ready to support business requirements.
* To ensure integration of key GMP requirements including procedural controls, facility controls, and training requirements to support on-time transition from project phase to operational use in line with project schedule and site QMS.
* To support validation documentation as required.
* To manage risk/identify potential gaps and implement strategies to mitigate them as relevant.
In this role, you will be responsible for ensuring that all activities are conducted to meet GMP regulations, site or corporate quality standards, and any additional regulatory requirements. You will also be required to manage information using site documentation management systems, deviation/CAPA/CC systems, and training systems. A Bachelor's or Master's degree in Chemistry or a related scientific field is required, with a minimum of 5 years of experience in the pharmaceutical industry in a similar role. The qualified candidate must demonstrate characteristics aligned with our company values and behaviors.
About Us:
We are a global Contract Development and Manufacturing Organisation (CDMO) with state-of-the-art facilities in Korea, US, France, and Ireland. Our mission is to produce and deliver life-changing therapies that improve patient outcomes and save lives. We have made some of the world's most important medicines and continue to do so.
Main Requirements:
* A Bachelor's or Master's degree in Chemistry or a related scientific field.
* Minimum of 5 years of experience in the pharmaceutical industry in a similar role.
* Strong initiative and leadership skills.
* Demonstrate characteristics aligned with our company values and behaviors.
Desirable Skills:
* Previous experience in QA CAPEX projects.
* QA Operational readiness.
* Validation requirements and handovers.
* Systems experience.
* Clinical to commercial manufacturing experience.
* Lean Six Sigma – proven track record improving QA Operations/Systems/Validation processes.
* Experience in regulatory inspections or part of Inspection readiness team.
What We Offer:
We offer a dynamic and supportive work environment, opportunities for career growth and development, and a competitive salary package.