Senior QA Validation Specialist

Job description

Nombre del sítio: Singapore - Tuas
Fecha de publicación: Feb 1 2024

Purpose

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To lead and manage Site validation activities (as assigned) to ensure that validations are in compliance with company procedures, regulatory requirements, and cGMP expectations.

· 
To provide QA compliance oversight over IT and Technical Services (as assigned)

Key Responsibilities Area

Ensure site validation activities are compliant with Site procedures, regulatory requirements, and cGMP expectations:

· 
Author and maintain the quality system SOPs for validation.

· 
Define validation approach that is technically sound and are compliant.

· 
Author Validation Plans and Reports, including Continuous Validation Plan

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Review and approve validation deliverables

· 
Provide solutions to achieve validation requirements

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Collaborate with Operations to define the validation schedule and support the timely completion of activities as per schedule

· 
Drive efficiency, improvement and robustness in site validation systems and processes.

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Be the link with Global Validation for technical information, and standards roll out

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Assess impact to validation and validation status during change management, and define appropriate validation requirements and approach to maintain validated status of systems

· 
Assess impact to validation for incidents/deviations and ensure appropriate CAPAs are in-place to resolve issues and prevent recurrence.

· 
Perform Periodic Review and prepare the review report for systems and processes.

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Oversee Periodic requalification and Continued process verification to maintain the validated status of systems and processes.

· 
Conduct GSK internal audits and front as SME in external regulatory inspections.

· 
Provide support for all activities related to GPS (e.g. Tiers, Gemba, DMAIC etc) for continuous improvement.

Provide QA Oversight to IT operations in areas of:

· 
QA consultation to review and approve SOPs

· 
Review and approve changes, deviations and CAPAs

1.      Provide QA compliance oversight to Technical Services

·       Interact with TS personnel in day-to-day operations to ensure cGMP compliance

·       Be the QA approver for TS activities including but not limited to

-        LSOPs, Deviation/Event, CAPAs, Change Controls,

-        Quality Tag-Outs

- Pest control reports

-        Calibration & maintenance programs Pest control reports

2.   Interface with Internal & External stakeholders

·       Effective interfaces with internal and external stakeholders to ensure effective communication with and cascades from Global functions

3. EHS

·  Comply with company requirements on EHS

Proposals & Recommendations

· 
Propose validation approach

· 
Propose areas of site validation improvement

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Identify potential compliance risk/ gaps and recommend improvement

· 
Identify improvement in quality processes.

Skills, Knowledge & Experience

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At least University basic degree in a Science or Engineering discipline

· 
At least 2 years' experience in pharmaceutical industry or related regulatory fields (at least 5 years for Senior QA Validation Specialist role)

· 
A good understanding of cGMP regulatory and legal requirements as applied to quality assurance and validation of pharmaceutical manufacturing

· 
Good understanding of regulatory inspection requirement

· 
A good working knowledge of validation, preferably with hands-on experience

· 
Computer skills in MS Office and familiar with web-based e-learning resources

· 
Potential or developing project management skills.

Nuestro objetivo es ser una de las empresas de atención médica más innovadoras, de mejor desempeño y más confiables del mundo. Creemos que todos aportamos algo único a GSK y cuando combinamos nuestros conocimientos, experiencias y estilos, el impacto es increíble. Únase a nuestra aventura en GSK donde se inspirará para hacer el mejor trabajo para nuestros pacientes y clientes. Un lugar donde puede ser usted mismo, sentirse bien y seguir creciendo.

  

Aviso importante a las empresas o agencias de empleo

GSK no acepta recomendaciones de empresas de empleo o agencias de empleo con respecto a las vacantes publicadas en este sitio. Todas las empresas o agencias de empleo están obligadas a ponerse en contacto con el Departamento de Contrataciones Comerciales y Generales o el Departamento de Recursos Humanos de GSK para obtener autorización previa por escrito antes de recomendar a cualquier candidato a GSK. La obtención de autorización previa por escrito es una condición precedente a cualquier acuerdo (verbal o escrito) entre la empresa o agencia de empleo y GSK. En ausencia de dicha autorización por escrito, se considerará que las acciones que emprenda la empresa o agencia de empleo se han realizado sin el consentimiento o el acuerdo contractual de GSK. Por lo tanto, GSK no será responsable de ninguna tarifa derivada de tales acciones o cualquier tarifa que surja de cualquier recomendación por parte de las empresas o agencias de empleo con respecto a las vacantes publicadas en este sitio.