Quality Systems Specialist

Client

Our client is a leading Project Management and Engineering company serving the pharmaceuticals industry around the world.

Bachelor’s degree in technical discipline (Chemistry/Microbiology/Engineering or similar).
Required: Minimum of 5 x years of Quality Assurance experience in a GMP environment (Drug Substance or Drug Product).
Working knowledge of quality systems and regulatory requirements (EU GMPs and ICHQ10)
Preferred: ASQ, Black Belt/Green Belt certifications. Experience with ATMPs.
Strong knowledge of GMPs, pharmaceutical Law and legislation
Experience with Change Control, CAPA, Internal Audit, Deviations, MRB and other ICHQ10 quality systems.
Strong knowledge of aseptic manufacturing processes.
Proficiency in MS Word, Excel, Power Point, Smartsheet, Power BI and Power automate and Quality management systems.
Strong written and verbal communication skills.
The role of a senior is very diverse and requires to be flexible, pragmatic and a team player.
Ability to communicate and work independently with scientific/technical personnel.
As we extend our global reach, we need colleagues interested in change, in challenge, and in building a new future together.

Ensuring, at site level or as a member of cross-site quality system committees, Quality Systems conform to regulations and quality policies.
Managing the Change Control system, deliver training (including administration) and act as (backup) chair of the Kite EU Change Control Review Board and other multidisciplinary teams associated with the subject.
Managing the Deviation and CAPA management systems, deliver training (including administration) and act as (backup) chair of the Kite EU Deviation Board.
Managing the Material review board process, act as (backup) chair of the Kite EU MRB.
Supporting coordination of multidisciplinary initiatives as part of Kite EU start up endeavors.
Supporting regulatory inspections and audits.
Ensuring proper maintenance and approval of cGMP documents.
Ensuring proper maintenance of the Kite Quality Management system.
Reviewing and approving proposed changes to systems and procedures.
Reviewing and approving deviations and CAPA records.
Tracking, reviewing, organizing and reporting metric and management information for use in continuous improvement and Quality Management Review.
Guiding and supporting the team with their day-to-day job.
In absence of the QS data analyst support reporting tools and automated workflows.
Identify and implement improvements in our QS processes.
Acting as backup for Sr Manager Quality Systems.
Performing other duties as required.