SENIOR PRODUCT COMPLIANCE SPECIALIST
Descripción de la oferta de empleo
At Johnson & Johnson, we believe health is everything.
Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal.
Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.
Learn more at https://www.
nj.
om/.
This position is responsible for the support/ownership of product compliance programs and activities to establish and maintain Johnson and Johnson Innovative Medicines licenses required to import and distribute Drug, Medical Device and Controlled Drug and Substances products in the Canadian Market.
Major Responsibilities.
Perform Establishment Licensing process (i.
.
reviewing annual requirements, obtaining necessary documentation from sites, preparing submissions, etc.) and direct communication with Health Canada foreign site unit on queries to Janssen Inc.
Canada.
Ensure the Purchasing Controls processes are effectively implemented and managed (e.
.
supplier and site monitoring and audits, and maintenance of related documents in e-QMS).
Build and maintain relationship with supply sites, wholesalers and key internal partners to implement agreements ensuring company and Canadian regulatory requirements are met in accordance to GMP’s and MRA frameworks where appropriate (Ensure Canadian requirements have been appropriately incorporated into the site’s procedures).
Liase/Negotiate with Health Canada and/or manufacturing/testing/supplier sites to ensure all processes are addressed as appropriate i.
.
Drug Surveillance, Group 3 Biologics, alignment with quality agreements and supporting programs.
Identify, investigate and resolve non-conformances, corrective and preventive actions in collaboration with internal and external business.
Partner/collaborate with key internal and external business partners to establish priorities, develop and manage systems/processes to support product compliance activities (Product release, GMP checks, validation review, APRs/Stability, Confirmatory testing, Executed Batch records, Inventory management, unique identifier, retain sample program, re-packaging at 3rd party operations).
Support new product launches and product site transfers ensuring that all Master Records and release specifications/documentation meet Health Canada marketing authorizations.
Negotiate with internal and external partners to resolve any gaps/deficiencies identified during this review.
Lead and support Health Canada and internal audits (direct interaction with auditors).
Develop and revise Standard Operating Procedures and Work Instructions as required and provide input to global and regional standards by ensuring that the Canadian perspective is integrated.
Evaluate changes to master production documentation to ensure alignment to marketing authorization (in collaboration with RA CMC).
Review and assess analytical, manufacturing and packaging documentation for finished products to ensure compliance to requirements/marketing authorization to timely complete product disposition in SAP.
Assess all data related to product returns to ensure all requirements are met for return to stock or recommend rejection.
Develop, implement, maintain and improve business processes based on identified issues.
Establish process metrics and monitor performance.
Ensure on going product compliance to Canadian Regulations and J&J Quality requirements through review and evaluation of Annual Product Reviews (APRs), Annual Stability reports, Supplier Release Documentation and Executed Batch Reviews.
Ensure regulatory compliance of all JI products through maintaining compliant specifications/standards (RSSs) and manages change to those standards.
This includes assessing impact on GMP quality requirements and regulatory filing (e.
.
changes to test methods, manufacturing and packaging).
Initiate, assess, and perform tasks related to change controls applicable to Canadian products Lead and/or participate in other quality projects as required.
Qualifications Job Knowledge Requirements.
Relevant knowledge and experience B.
C.
in Science with preference to Pharmacy, Chemistry, Microbiology, Biotechnology, or Biochemistry.
Ability to lead and apply requirements of Post NOC changes and to interpret GMPs and application of their intent within the business environment.
Understands principles of product change management and the impact on marketing authorization.
5 years Pharmaceutical Quality Control/Quality Systems.
Strong understanding of pharmaceutical production processes i.
.
manufacturing, packaging, testing and process validation with pharmaceutical manufacturing experience preferred.
Proficient in SAP.
Experience with S4 HANA is preferred.
Core/Technical competency requirements.
Delivers on commitments and is a positive role model for the Department/Division by modeling and inspiring high levels of ethics and integrity.
Builds and Fosters networks and relationships to ensure collaboration and integration across all business partners and communicates effectively with Health Authorities or other Auditors.
Ability to interpret GMPs and application of their intent within the business environment.
Balance customer needs and business demands to move the business forward.
Demonstrated sound judgment in managing risk on compliance matters resulting in positive outcomes.
Promotes and leverages the contribution of people with diverse ideas, perspectives and backgrounds.
Global and enterprise-wide mindset shaping short-term and long-term strategies by demonstrating innovative thinking and program development.
Presents a united front by actively supporting team decisions.
Displays resilience in the face of obstacles, adversity and/or major change while maintaining operating effectiveness.
Manage multiple priorities including owning and balancing project management in addition to daily work.
Working Conditions Job Location.
Toronto ON, Canada Office Environment Occasional need to travel locally, within Canada and internationally.
Physical/Auditory & Visual Demands.
Majority of work day is spent in an office environment working on a computer.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.
areers.
nj.
om.
Detalles de la oferta
- Sin especificar
- 27/01/2025
- 27/04/2025
Report to the operations specialist and coordinate daily interventions and tasks... great english and spanish fluency (b2-c1 level both written and spoken) being already in possession of a permit to work in spain or the eu other features that would help a lot: effective communication with the operations......
Ensure compliance with local labor laws and company policies... thisworks supports companies in hiring talent across europe while ensuring compliance with local regulations... thisworks, a netherlands-based provider of employer of record (eor) services, payroll solutions, and work permit assistance,......
Estamos buscando un asistente de atención médica senior para coordinar la prestación de atención médica... asistente de atención médica senior - coordinador de turnos - car home / asistencia domiciliaria - turnos de día y de noche - centro de atención continua y domiciliaria - cornwall reino unido reach......
Estamos buscando un asistente de atención médica senior para coordinar la prestación de atención médica... asistente de atención médica senior - coordinador de turnos - asistencia domiciliaria / asistencia domiciliaria - turnos de día y noche - centro de atención continua y domiciliaria - cornwall reino......
We are looking for a junior technical customer success specialist to join our customer success team... a computer with the following parameters: ram - 16 gb or higher (for windows); 8 gb or higher (for mac os)... availability for 40 hours per week (5 days a week) in agreed rotating timelines (including......
Técnicos senior de radiología - reino unido - unidad de salud móvil de imágenes reach hr es una empresa especializada en la contratación de profesionales sanitarios... rhr busca contratar técnicos de radiología para trabajar como proveedores de diagnóstico y atención médica para el nhs, el servicio nacional......
Liu jo está buscando para su store en paseo de gracia, barcelona un (a) senior sales assistant... tipo de puesto: jornada completa, contrato indefinidootros datos del puestohorario: turno rotativo experiencia: ventas: 2 años (deseable) fecha de inicio prevista 20/04/2024......
Descripción del puesto: confidencial cuenta con una posición como public relations specialist para crear y mantener una imagen positiva de la empresa a través de estrategias de comunicación efectivas con los medios y el público... gestionar las relaciones con los medios de comunicación y periodistas......
B2b recursos humanos select luxury customer service specialist for consolidated business group dedicated to providing services related to tourism, short term rentals and flexible accommodations... track all ota, direct, and agent leads, updating the pms as needed... the opportunity to meet guests from......
Persona proactiva y resolutiva, que sepa dar soluciones a los problemas planteados... procesos de negocio (desarrollos en software erp, etc... posibilidad de participación accionarial en la empresa... buscamos una persona interesada en nuestro proyecto empresarial a medio y largo plazo, que se implique......