TnP Trainee - QA Executive

Job description

Nombre del sítio: Singapore - Tuas
Fecha de publicación: Feb 21 2023

Career Conversion Programme for (Train-and Place with commitment to hire) Advanced Biopharmaceuticals Manufacturing Executives/Professionals is a manpower development programme jointly supported by Workforce Singapore (WSG) and Temasek Polytechnic (TP).

The training programme consists of a 3-months structured facilitated training conducted by Temasek Polytechnic, followed by 15 months of local attachment with GSK. Due to the nature of the programme, we can only consider Singapore Citizens and Singapore Permanent Residents. For more information, please visit website ( WSG | Career Conversion Programmes (CCP) for Individuals )

A certificate will be given to successful trainees upon completion of the programme.

Purpose:

Perform QA oversight and manage quality compliance issues related to manufacturing and batch usage decision activities so as to maintain cGMP compliance in line with GSK and regulatory standards.

Key Responsibilities:

Quality Oversight:

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

· 
Support compliance in production area by routinely conducting QA checks such as checklist review, housekeeping checks, review of line clearance checks, verify compliance with SOPs,etc.

· 
Authorise campaign changeovers and participate in facility walkdown where required.

· 
Provide quality input and assistance in managing unplanned event investigations, CAPA implementation and change control monitoring.

· 
Ensure changes implemented on production areas are properly managed to prevent potential adverse impact to operations.

· 
Authorise QA processes e.g. Production Process Orders, Quality Tag Outs, Equipment releases, Room releases etc.

· 
Lead and coach a team of QA Executives to perform quality oversight activities. (For Lead Role Only)
 

Review and approval of the following documentation as assigned:

· 
LSOPs / Checklists

· 
Master Batch Records

· 
Deviations / Events

· 
CAPAs

· 
Change controls

· 
Quality tag outs

Review and approval of executed Batch Records as assigned:

· 
Review of completed batch records and checklists (sterile buffers, intermediates and final adsorbed bulk).

· 
Monitor the quality of executed batch records and initiate actions as required.

Batch Usage Decision:

· 
Perform quality review of buffers and intermediates for suitability to move batch status to "Restricted" where required for batch forward processing.

· 
Complete QA review of the sterile buffers and/or intermediates and take appropriate usage decisions.

· 
Move intermediate batches to restricted status

· 
Approve checklist and logbook review summary section for batch release review summary form
 

Other activities as assigned , for examples:

· 
Support site complaint investigation

· 
Support periodic quality product review

· 
Perform internal audits

· 
Perform risk assessment and/or gap analysis.

· 
Site KPI reporting etc. (For Lead Role Only)

EHS

· 
Comply with company requirement on EHS

Management and Planning (For Lead Role Only):

· 
Lead and supervise team of QA Executives to perform quality operations

· 
Plan and organise team's day to day activities

· 
Report escalated quality issues to Line manager and key progress

Training and Development (For Lead Role Only):

· 
Plan and develop working knowledge and stakeholder management of the team of QA Executives
 

Decision Making:

Proposals & Recommendations

· 
Identify potential compliance risks/ gaps and recommend improvements

· 
Identify improvement in quality processes and propose quality improvement strategies.

· 
Recommend direct report performance evaluation and training needs. (For Lead Role Only)
 

Skills:

Snr QA Executive 1 or 2

Professional

· 
University degree in relevant Science or Engineering discipline.

· 
At least 3 years of experience in pharmaceutical industry preferred.

Technical

· 
Good understanding of GMP standard and regulatory requirements of pharmaceutical 'FldLlSt”

· 
User experience with SAP preferred

· 
Basic understanding of regulatory inspection requirement.

Business

· 
Ability to apply optimal quality assurance standards to promote business edge.

· 
Ability to communicate effectively within the site organisation and possess good people management skills.

· 
Ability to apply risk management skills adequately

QA Lead
 

Professional

· 
University degree in relevant Science or Engineering discipline.

· 
At least 6 years of experience in pharmaceutical industry preferred.

Technical

· 
In-depth understanding of cGMP regulatory and regulatory requirements of pharmaceutical ""ldUSt”

· 
User experience with SAP preferred

· 
Good understanding of regulatory inspection requirement.

· 
Extensive knowledge and hands-on experiences of pharmaceutical manufacturing processes.

Business

· 
Ability to apply optimal quality assurance standards to promote business edge.

· 
Ability to communicate effectively within the site organisation and possess good people management skills.

· 
Ability to apply risk management skills adequately

Competencies:

· 
Good Knowledge of FDA / EU/ ICH/ WHO as well as other relevant regulatory and technical guidelines.

· 
Possess analytical and quality perofrmance mindset

· 
Demonstrate professional and ethical integrity

· 
Proficiency in English.

· 
Leadership qualities and supervisory skills. (For Lead Role Only)

Where will I be based?

You will be based at one of our manufacturing site in Singapore near Tuas.

When can I start?

CCP Program starts in March 2023 (tentatively), while the On the Job training start in Sept 2024.

How can I apply?

Applications are now open. Click on the button above to apply.

Applications close 17 Feb 2023 ( We recommend you apply as soon as possible, because we accept ongoing applications and offer positions on a first come, first served basis!)

At GSK we value diversity and treat all candidates equally. We strive to make our recruitment process free of bias of any kind and aim to create an inclusive workplace at GSK. If you require any assistance, either to attend an interview or during the course of the recruitment process, please let us know.

Why GSK?
 

Uniting science, talent, and technology to get ahead of disease together 

At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Healthcare, strengthening our leadership, and transforming our commercial execution. Now, we’re making the most significant changes we’ve made to our business in over 20 years. We’re on track to separate and create two new companies in 2022: New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and genetics science; and a new world-leading consumer healthcare company of loved and trusted brands. 

With new ambition comes new purpose. For New GSK, this is to unite science, talent, and technology to get ahead of disease together – all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; and as a new GSK where outstanding people thrive. 

Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culture that is  ambitious for patients  – so we deliver what matters better and faster;  accountable for impact  – with clear ownership of goals and support to succeed; and where we do the right thing . So, if you’re ready to improve the lives of billions, join us at this exciting moment in our journey. Join our challenge to get Ahead Together. 

 

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.