Quality Management Systems

3 weeks ago

Singapur, Singapore 825 Glaxo Wellcome Manufacturing Pte Ltd Full time

To lead, support and maintain effective and compliant quality systems relating to:

Change Control System

Quality Management System (QMS)

Quality Alerts and Quality Bulletins

Deviation Management System

Corrective Action and Preventive Action (CAPA) System

Product Quality Review (PQR)

General

For each assigned Quality System(s) :

Lead in its design and maintenance to be compliant with regulations, QMS, company policies and site specific requirements

Be the subject matter experts (SMEs) for the site

Be proficient in the respective SAP and IT modules

Provide business support to site employees

Review and revise the relevant SOPs

Manage the relevant training programs, such as maintaining the training schedule, training materials and trainers

Perform gap assessments between local procedures and above-site documents, such as Vaccines SOPs (VSOPs) and QMS

Perform periodic reviews as required, such as annual Deviation Management System review

As a site representative, create effective interfaces with internal and external stakeholders such as global and fellow process owners to share best practices and drive continuous improvements

Quality Management System

1. Site Change Control

Runs the regular site Change Control Board and implementation committee meetings with relevant stakeholders

Ensures the consistent application of criteria to determine change control levels for each proposed change

Review and monitor the health of the Change Control system on site; e.g. change control status, duration of change controls and provide relevant metrics to SQC

2. Quality Management System (QMS)

Be the site champion for the QMS

Keeps track of QMS/VSOP revisions and enforce gap assessment timelines on site

Assesses the cumulative risks of open QMS/VSOP gaps on site

3. Quality Alert and Quality Bulletins

Work with internal stakeholders to manage and coordinate the site's responses to Quality Alerts and Quality Bulletins in a timely and effective manner

Summarizes all received Quality Alerts / Bulletins and reports them to SQC

Professional

At least University basic degree in a Science or Engineering discipline.

Preferably 2 years' experience in the pharmaceutical industry in GMP regulated areas and 5 years or more for the role of the Senior QA Executive.

Technical

A good understanding of cGMP regulatory and legal requirements as applied to quality assurance of pharmaceuticals manufacturing.

A good working knowledge of Deviations, CAPA, change controls and Product Quality Review with hands-on experience will be preferred

To learn more about Singapore GSK and our people, please click on this link:

#Li-GSK

Why GSK?

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

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK.

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