Quality Specialist ComplianceNetherlands - HoofddorpQualityRegular
Descripción del trabajo
As Quality Specialist Compliance you support the deployment or management of Kite Pharma Site Compliance as part of the department Quality Systems and Compliance. The position interfaces, as compliance partner, with many departments and internal and cross site stakeholders.
Kite, A Gilead Company
At Kite, we are at the forefront of immunotherapy and engineered T cell therapy. We are helping change the paradigm of cancer treatment and we are revolutionizing individually tailored treatments. That means a fast moving and constantly changing environment, where we make discoveries every day – discoveries that include our own capabilities and our individual potential.
We’re currently seeking to recruit highly motivated talents for different positions, to join us and be part of our exciting journey in the development of innovative cancer immunotherapies and their translation to the treatment of patients with cancer.
As Quality Specialist Compliance you will be joining the Quality Systems & Compliance team in which people of all backgrounds and experiences are respected. The sub team Quality Systems Compliance is responsible for the systems and activities listed below of which ownership is divided among the team. You will be reporting to the Director Quality Systems and Compliance.
Responsibilities (include but are not limited to):
Support at site level or as a member of cross site Compliance committees, conformance to regulations and quality policies
Support site internal audit program and conducts internal audits ensuring compliance of site processes and systems to, EU and ROW regulatory requirements
Manage/ Monitor all aspects of the audit lifecycle: scheduling, planning, issuing agendas, executing, issuing reports, evaluating responses, requesting clarification, issuing CAPA,
Participate in the development, implementation and maintenance of procedures and templates to assist in the execution of the site audit program
Assist in development of effective auditing tools and training aids
Participate in Site Inspection Readiness and inspection management programs
Support regulatory inspections and audits
Ensure proper maintenance and approval of cGMP documents,
Identify compliance risks and escalate issues to appropriate levels of management for resolution
Provide compliance guidance to technical transfer activities, as required
Support tracking and reporting metrics and management information for use in continuous improvement and Quality Management Review
Support the Compliance system, (AGILE) and deliver training (including administration)
Support generation of annual quality reports
Additional job duties as required.
Bachelor’s degree in technical discipline (Chemistry/Microbiology/Engineering or similar) with 5+ years of relevant experience in the pharmaceutical industry
Strong understanding of a GMP working environment
Strong knowledge of GMPs, ATMP (pre), Pharmaceutical Law and legislation
Prior experience in pharmaceutical industry, cell therapy, biologics, blood/human tissue, or vaccines experience is a pre
Ability to troubleshoot and resolve technical issues
Proficient with computers and word processing software (i.e. Microsoft Office products)
Demonstrates good interpersonal, verbal and written communication skills, which are essential in this collaborative work environment
Ability to work effectively in a team environment
Ability to works under light supervision utilizing good time management skills
Working location is Hoofddorp.