- Location
- Jobos, Guayama
- Type
- Full-time
- Closing date
- Today
- Source
- Vincere
Description
Descripción del Puesto y Formulario de Requisitos de Adiestramiento del Puesto (Job Description and Role Training Requirements Form)
Propiedad de Consumer Healthcare (CH) No puede ser utilizada, divulgada o publicada sin el consentimiento de CH. Sólo las versiones controladas son válidas. Documento firmado electrónicamente (Veeva) y (myLearning).
Property of CH May not be used, divulged, published, or otherwise disclosed without the consent of CH. Only the controlled versions are valid. Document electronically signed (Veeva) / acknowledge (myLearning).
Descripción del Puesto (Job Description)
Título del Puesto (Job Title)
Label Change Coordinator Departamento
(Department) Technical Services
Puesto del Supervisor
(Manager Job Title) Technical Services Packaging Leader
Fecha de Efectividad
(Effective Date)
Cuando se apruebe (When approved)
Propósito del Puesto (Job Purpose)
Applies advanced technical process solutions in packaging technology and process, ensuring priorities are align with customer needs, technology management objectives, company goals and government regulations. Implements new packaging technologies for the Site. Leads all the packaging process qualifications and validations.
The incumbent must be capable of leading cross-functional projects with some direct involvement from their supervisor. Troubleshoots and resolves moderate to highly complex packaging process issues, diagnosing technical problems and determining short- and long- term solutions. Pack ag ing p rojects must achieve business, quality, and compliance objectives, and must be executed in a manner that assures full compliance with government regulations and internal company standards and values.
Responsabilidades (máximo de 10) (Key Responsibilities -10 bullet points maximum) Describir las responsabilidades claves que el titular del puesto debe realizar. (Describe the key deliverables to be achieved by the post holder and the ongoing responsibilities of the role)
Identifies opportunities and contributes to the development of solutions for quality process improvements, yield, efficiency, profitability or compliance improvements related to packaging process. Implementation of packaging process and technologies for new products and to changes to the existing packaging process. Identification and implementation of packaging process improvements. Provides the Technical support to packaging areas for quality issues. Provides the Technical support to packaging areas to improve line efficiency. Actively support readiness for Regulatory audits and meeting commitments from such audits Develops and executes Validation Strategies for new packaging processes and configurations Completion on time of action items for Packaging Tech Transfer of consumer products Identification & implementation of packaging improvements in new process, new packaging configurations and new products. Active participation in Regulatory inspections
Número de Empleados Directos (Number of Direct Reports)
Cantidad de empleados que se reportan directamente al Supervisor, Líder, Gerente o Director (Quantity of Direct Reports)
None
máximo de 10)
in packagingpackaging needs,needs, technologytechnology
regulations. Implements newImplements new process process qualificationsqualifications
of leadingof leading crosscross--functionalfunctional TroubleshootsTroubleshoots andand
diagnosing technicaltechnical problemsproblems rojects mustmust achieveachieve
executed inin aa mannermanner companycompany standardsstandards
(Key Responsibilities as responsabilidades claves que el titular del puesto the key deliverables to be achieved by the post holder and the ongoing responsibilities of the role)
andand contributescontributes yield,yield,
Título del Puesto (Job Title)
Label Change Coordinator Departamento
(Department) Technical Services
Puesto del Supervisor
(Manager Job Title) Technical Services Packaging Leader
Fecha de Efectividad
(Effective Date)
Cuando se apruebe (When approved)
Conocimiento/ Educación / Experiencia Requerida (Knowledge/ Education / Experience Required)
A. Formación académica (Educational Background) Enumere cualquier educación académica o práctica que se debe obtener para estar calificado para desempeñar este rol. (List any academic or practical education that must be obtained to be qualified to perform this role)
1.Nivel Mínimo y/o Preferido de Educación
(Minimum and Preferred Level of Education)
BS Engineering
2. Área de Especialización
(Area of Specialization) Industrial or Mechanical
B. Experiencia relacionada con el puesto (Job-Related Experience) Describa qué experiencia requerirá que el titular del puesto haya obtenido en roles anteriores dentro o fuera de CH que demuestren un nivel de competencia en el rol establecido. (Describe what experience this position will require the job holder to have obtained in past roles within or outside of CH that would demonstrate a level of proficiency in the stated role)
Nivel de Experiencia Requerida Relacionada con el
Puesto (Level of Job-Related Experience
required)
Three (3) to five (5) years of experience in pharmaceutical industries plus supervisory experience or equivalent
C. Otras destrezas / historial relacionados con el puesto (Other Job-Related Skills/Background) Enumere las licencias, certificados, registros o cualquier destreza o habilidades laborales que no esté cubierta en las secciones de Educación o Experiencias. (List any licenses, certificates, registrations, or any relevant job skill or abilities not covered in Educational Background or Job-Related Experience sections above that are required for the job)
Self-starter, team player, with strong interpersonal skills
Excellent written and verbal skills in English Computer literate
D. Demandas Físicas y Mentales (Physical and Mental Demands)
Office environment minimal risks, ability to travel.
E. Declaración de Cumplimiento (Compliance Statement)
Guayama está comprometida con la entrega de productos seguros y efectivos a pacientes y consumidores. Se requiere que todos los empleados:
Ejecuten sus responsabilidades con el compromiso por la calidad, siguiendo los procedimientos establecidos, las guías corporativas Lleven a cabo todas las operaciones de manufactura de acuerdo con los principios de saneamiento adecuados. Informen sobre problemas y preocupaciones de calidad a través de los procesos corporativos o de Guayama CH.
Guayama is committed to the delivery of safe and effective products to patients and consumers. It is required that all employees:
Execute their responsibilities with proper regard for quality, following site procedures, corporate quality guidelines and cGMPs. Conduct all manufacturing operations in accordance with adequate sanitation principles. Reporting quality issues and concerns through appropriate site or corporate processes.
, team player, with strong interpersonal skills, team player, with strong interpersonal skills
relacionados con el Skills/Background)
Enumere las licencias, certificados, registros o cualquier o Experiencia (List any licenses, certificates, registrations, or any relevant job
Industrial or Mechanical
Experience haya obtenido
establecido. (Describe job holder to have obtained in past roles within or outside of CH that would demonstrate a level of proficiency in the
Three (3) to five (5) years of experience in pharmaceutical Three (3) to five (5) years of experience in pharmaceutical industries plus supervisory experience or equivalentindustries plus supervisory experience or equivalent
not covered in Educational Background or Job
Excellent written and verbal skills in EnglishExcellent written and verbal skills in English
Título del Puesto (Job Title)
Label Change Coordinator Departamento
(Department) Technical Services
Puesto del Supervisor
(Manager Job Title) Technical Services Packaging Leader
Fecha de Efectividad
(Effective Date)
Cuando se apruebe (When approved)
Declaración de Cumplimiento para Líderes, Gerentes y Supervisores N/A
Tomar medidas para excluir de las operaciones a cualquier persona que pueda ser una fuente de contaminación microbiana debido a una condición de salud siguiendo los procedimientos. Supervisar las prácticas generales de saneamiento y garantizar que el personal esté capacitado en los procedimientos de saneamiento, que incluyen lavarse bien las manos (y desinfectar, si es necesario, para protegerse contra la contaminación con microorganismos) en una instalación adecuada para lavarse las manos:
o Antes de comenzar a trabajar; o En cualquier momento en que las manos puedan haberse ensuciado o
contaminado. Supervisar y asegurar que el personal esté capacitado en los procesos para prevenir la contaminación de componentes o productos mientras realiza operaciones de manufactura para evitar el crecimiento potencial de microorganismos y el potencial de contaminación.
Compliance Statement Leads, Supervisors, Managers
Take measures to exclude from operations any person who might be a source of microbial contamination due to a health condition following site procedures. Supervises overall sanitation practices and ensures personnel is trained in the sanitation procedures, which include washing hands thoroughly (and sanitizing, if necessary, to protect against contamination with microorganisms) in an adequate hand-washing facility:
o Before starting work; and o At any time when the hands may have become soiled or contaminated
Supervises and ensures personnel is trained in the processes to prevent contamination of components or products while performing manufacturing operations to avoid potential growth of microorganisms and the potential for contamination.
que el personal esté capacitado en los procesos para prevenir la contaminación de componentes o productos mientras realiza operaciones de contaminación de componentes o productos mientras realiza operaciones de para evitar el crecimiento potencial de microorganismos y el potencial de contaminaciónpara evitar el crecimiento potencial de microorganismos y el potencial de contaminación
Take measures to exclude from operations any person who might be a source of microbial contamination due to a Take measures to exclude from operations any person who might be a source of microbial contamination due to a
Supervises overall sanitation practices and ensures personnel is trained in the sanitation procedures, which include Supervises overall sanitation practices and ensures personnel is trained in the sanitation procedures, which include washing hands thoroughly (and sanitizing, if necessary, to protect against contamination with microorganisms) in an washing hands thoroughly (and sanitizing, if necessary, to protect against contamination with microorganisms) in an
At any time when the hands may have become soiled or contaminatedAt any time when the hands may have become soiled or contaminated Supervises and ensures personnel is trained in the processes to prevent contamination of components or products Supervises and ensures personnel is trained in the processes to prevent contamination of components or products while performing manufacturing operations to avoid potential growth of microorganisms and the potential for while performing manufacturing operations to avoid potential growth of microorganisms and the potential for
Requisitos de Adiestramiento del Puesto (Role Training Requirements)
Nivel 1: Mandatorio (Level 1: Mandatory)
ID del Currículo (Curriculum ID)
Descripción (Description)
BUS-PAP-ACTIVE-SHOOTER- TRG-CUR
Active Shooter Preparedness and Haleon Security Training Curriculum -US
BUS-PAP-COC-ABAC_12_2023 Our Code of Conduct and Anti-Bribery & Anti-Corruption 2023
Nivel 2: Esperado (Level 2: Expected)
ID del Currículo (Curriculum ID)
Descripción (Description)
MFG-040-GU-B-ALL-COLL- GMP
All Colleagues GMP Requirements
MFG-040-GU-B-ALL-COLL- EHS
All Colleagues Environmental Health & Safety Requirements
MFG-040-GU-B-IND-FTE CH Induction Program for New Employee in Manufacturing Site
MFG-040-GU-B-EHS-04 Ergopoint Display Screen Equipment Programme
MFG-040-GU-B-GMP-YEAR Annual Refresher for All PCH Colleagues-YEAR
CH-GU-L-QD-TRN- 21827 Descripción del Puesto y Formulario de Requisitos de Adiestramiento del Puesto Technical Services Packaging Scientist
MFG-040-GU-B-TS-I15 Label Change Coordinator
MFG-040-GU-B-TS-01 General Technology Requirements
MFG-040-GU-B-TS-EHS Technology Services- EHS Requirements
Nivel 3: Esperado y/o Opcional (Level 3: Expected and/or Optional)
ID del Currículo (Curriculum ID)
Descripción (Description)
ICE-CHC-EHS-003 ICE-CHC-EHS-003 CH Pack Specification Management
ICE-CHC-PAP-094 ICE-CHC-PAP-094 CH Pack (Ensur) System User Manual
Nivel 3: Esperado y/o Opcional (Level 3: Expected and/or Optional)
ID del Currículo (Curriculum ID)
Descripción (Description)
ICE-CHP-001 ICE-CHP-001 CH Pack-Overview-Training Modules
ICE-CHP-002 ICE-CHP-002 CH Pack-Create and Change Packaging Documents- Training Module
All Colleagues GMP RequirementsAll Colleagues GMP Requirements
All Colleagues Environmental Health & Safety RequirementsAll Colleagues Environmental Health & Safety Requirements
CH Induction Program for New Employee in CH Induction Program for New Employee in
Ergopoint Display Screen Equipment ProgrammeErgopoint Display Screen Equipment Programme
Annual Refresher for All PCH ColleaguesAnnual Refresher for All PCH Colleagues
DescripciónDescripción deldel AdiestramientoAdiestramiento ScientistScientist Label Change CoordinatorLabel Change Coordinator
General Technology RequirementsGeneral Technology Requirements
ICE-PSX-012_ES PAS-X Read Only Access_ES
MFG-040-CH-B-004 GxP Governing Documents Author
MFG-040-CH-B-094 MFG-040-CH-B-094: CH Change Control Owner
MFG-040-CH-B-130 MFG-040-CH-B-130: CH QS - Investigation of Out of Specification or Atypical Results
MFG-040-CH-B-191 MFG-040-CH-B-191: CH Change Control Action Owner
MFG-040-CH-B-209 MFG-040-CH-B-209: QS-Deviations Management Owner Role
MFG-040-CH-B-211 MFG-040-CH-B-211: CH QS Investigation, Root Cause and CAPA - Full Training
MFG-040-CH-B-213 GxP Governing Documents Approver
MFG-040-CH-B-267 MFG-040-CH-B-267: Personnel and Training Management - All personnel
MFG-040-CH-B-CIPO Continuous Improvement Process Owner/Approver
MFG-040-CH-B-TP-002 MFG-040-CH-B-TP-002: Compliance Training in a Regulated Environment with knowledge refresher
MFG-040-CH-B-VQDARV MFG-040-CH-B-VQDARV: CH Veeva QualityDocs - Approver / Reviewer / Verifier
MFG-040-CH-B-VQDARV_ES VEEVA Docs de Calidad Aprobador Revisor Verificador
MFG-040-CH-B-VQDAUT MFG-040-CH-B-VQDAUT: CH Veeva QualityDocs - Author
MFG-040-CH-B-VQDEDIT MFG-040-CH-B-VQDEDIT: CH Veeva QualityDocs - Editor
MFG-040-CH-B-VQMS- CREATOR
CH Veeva QMS Record Creator/ Contributor
MFG-040-GU-B-AUTOM- USER SEC
Automation User Security
MFG-040-GU-B-QA-20 CH-GUA-Veeva Local Quality Docs (SOP's and Forms)
MFG-040-GU-B-QA-21 CH-GUA-Veeva Local Quality Docs (Technical Documents)
MFG-040-GU-B-QTS-CM-RP Change Management - Responsible Person
MFG-040-GU-B-TS-01 General Technology Requirements
MFG-040-GU-B-TS-02 Cleaning Validation
Nivel 3: Esperado y/o Opcional (Level 3: Expected and/or Optional)
ID del Currículo (Curriculum ID)
Descripción (Description)
MFG-040-GU-B-TS-04 Equipment Qualification
MFG-040-GU-B-TS-05 Packaging Validation
TEC-095-119_CUR_R_XX TEC-095-119_CUR_R_XX_ERP BI Reporting
Continuous Improvement Process Owner/ApproverContinuous Improvement Process Owner/Approver
TP-002: Compliance Training in a Regulated 002: Compliance Training in a Regulated Environment with knowledge refresherEnvironment with knowledge refresher
BB--VQDARV: CH Veeva QualityDocs VQDARV: CH Veeva QualityDocs Reviewer / VerifierReviewer / Verifier VEEVA Docs de Calidad Aprobador VEEVA Docs de Calidad Aprobador
040-CHCH-B-VQDAUT: CH Veeva QualityDocs VQDAUT: CH Veeva QualityDocs
MFGMFG-040040-CHCH--BB-VQDEDIT: CH Veeva QualityDocs VQDEDIT: CH Veeva QualityDocs
CH Veeva QMS Record Creator/ ContributorCH Veeva QMS Record Creator/ Contributor
Automation User SecurityAutomation User Security
CHCH
TEC-095-1205_CUR_es TEC-095-1205_CUR_es_Managing & Controlling Change
TEC-095-1223_CUR_en TEC-095-1223_CUR_en_New Product Introduction
TEC-095-1224_CUR_en TEC-095-1224_CUR_en_Pack Management
TEC-095-1225_CUR_es TEC-095-1225_CUR_es_Task Management
TEC-095-1226_CUR_es TEC-095-1226_CUR_es_Master Data - Data Provision
TEC-095-1237_CUR_es TEC-095-1237_CUR_es_Item Task Management
TEC-095-1238_CUR_es TEC-095-1238_CUR_es_General Action Notification Management
TEC-095-1300_CUR_es TEC-095-1300_CUR_es_Maintenance Work Initiation
TEC-095-130_CUR_R_XX TEC-095-130_CUR_R_XX_ERP Access - Requestor
TEC-095-136_CUR_R_XX TEC-095-136_CUR_R_XX_Global ERP Shared Pack Process
TEC-095-1408_CUR_es TEC-095-1408_CUR_es_Provide Planning and Production Master Data
TEC-095-1506_CUR_es TEC-095-1506_CUR_es_Engineering Change Management
TEC-095-1507_CUR_es TEC-095-1507_CUR_es_Batch Document Management
HISTORIAL DE REVISION
Sección de Aprobación (En caso de que el Sistema electrónico no esté disponible se utilizará esta sección)
Supervisor del Puesto: Fecha:
Especialista de Adiestramiento: Fecha:
136_CUR_R_XX_Global ERP Shared Pack Process
1408_CUR_es_Provide Planning and Production Master 1408_CUR_es_Provide Planning and Production Master
1506_CUR_es_Engineering Change Management1506_CUR_es_Engineering Change Management
1507_CUR_es_Batch Document Management1507_CUR_es_Batch Document Management
de que el Sistema electrónico no esté disponible
Versión: 1.0 Fecha de Efectividad:
Ver encabezado Originador(es): Maytee Rodriguez
Noemi Rojas
Justificación del Cambio:
Se modificó el formulario en su totalidad con los nuevos requisitos para añadir la Descripción del Puesto.
Documentos Impactados Sección/Paso y Cambios Detallados
Se modificó el formulario en su totalidad con los nuevos requisitos para añadir la Descripción del Puesto.