Quality Systems Specialist Senior

Job Title: Quality Systems Specialist

Location: Hoofddorp, NL

Contract: 12M

Hours: 40H p/w

Shift pattern:

Salary: On request

Please note: this role does not offer any VISA sponsorship, to be eligible for the role you must be an EU Citizen

i-pharm consulting is working with a global biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. We are seeking a highly motivated individual to join their team in Hoofddorp, NL as a Quality Systems Specialist.

Who we're looking for

• An experienced individual with strong knowledge of GMPs, pharmaceutical Law and legislation
• Experience with Change Control, CAPA, Internal Audit, Deviations and other ICHQ10 quality systems
• Strong knowledge of aseptic manufacturing processes.
• Proficiency in MS Word, Excel, Power Point and exception management systems
• Bachelor's degree in technical discipline (Chemistry/Microbiology/Engineering or similar).
• Minimum of 5 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 written and verbal communication skills.
• Ability to communicate and work independently with scientific/technical personnel.

If this sounds familiar, then this vacancy is for you!

The Role

As a Quality System Specialist, you support the deployment or management including training of our companies Quality Systems in a broad sense. The position allows breakdown into 3 main categories but the Specialist interfaces, as compliance partner, with many departments and internal and cross site stakeholders.

• Joint maintenance, site system ownership and training of cross site procedures such as Change Control, Deviation and CAPA management and Internal Audit,
• Continuous governance and management reporting of site compliance with the quality system's procedures
• Identification of quality risks in activities and processes according to regulatory agency guidelines and Kite quality policies and procedures.

Who you'll be joining

As Specialist Quality Systems you'll be joining the Quality Systems team that covers, in addition to the below listed duties, training and document control disciplines, a small team in which people of all backgrounds and experiences are respected, and where working together focused on saving lives, by finding the cure for cancer, is a daily activity. You'll be reporting to the Quality Systems Senior Management.

Your Responsibilities

In this role, your responsibilities, among others, will be:

• Ensuring, at site level or as a member of cross site quality system committees, Quality Systems conformance to regulations and quality policies,
• Managing the Change Control system, deliver training (including administration) and act as (backup) chair of the 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 Deviation Board,
• Supporting coordination of multidisciplinary initiatives as part of start-up endeavours,
• Supporting regulatory inspections and audits
• Ensuring proper maintenance and approval of cGMP documents,
• Ensuring proper maintenance of the Exception Management system,
• Reviewing and approve proposed changes to systems and procedures,
• Providing compliance guidance to product development projects and technical transfer activities, as required,
• Tracking, reviewing, organizing and reporting metric and management information for use in continuous improvement and Quality Management Review.
• Performing other duties as required.

If you are interested in finding out more about this role or others, please contact Manpreet Bhullar at mbhullar@i-pharmconsulting.com or call +44020 7551 0802