TnP Trainee
1 month ago
Description
The Career Conversion Programme (CCP) (Train-and-Place with Commitment to Hire) for Advanced Biopharmaceuticals Manufacturing Executives/Professionals is a talent development programme aimed at building the next generation of skilled manpower for Singapore’s Biopharmaceuticals manufacturing industry in anticipation of hiring demand.
A certificate will be given to successful trainees upon completion of the programme.
Purpose:To be responsible for managing the interactions with third party organisations that supply QA incoming materials and/or services to GSK.
To manage material release for incoming materials, supplier change notifications and new material management.
To provide Quality oversight to logistics management and warehouse operations.
Key Responsibilities:Supplier Management
Provide QA oversight of Supplier management activities on site to achieve compliance with company policies and government regulations as assigned.
To participate (Executive 1) and to represent the site (Executive 2) for Supplier Management business processes to drive improvements and share best practises across the GSK Vaccines network.
Process owner/support supplier complaint process for QA incoming materials. Lodge supplier complaints and ensure suppliers identify the root cause and associated CAPA's to prevent recurrence of supplier quality issues.
Review and track supplier-related CAPA for timely closure.
Maintain inspection readiness, conduct supplier assessments for both new and current service providers in a timely manner.
Maintain the approved supplier listing and audit schedule in a state of compliance and accuracy.
Assess supplier change notifications in a timely manner and escalate where necessary especially in situations with supply impact.
Initiate and review deviations/change control/CAPA associated with incoming material.
Executive 1: Minor deviations and CAPAExecutive 2: Minor, major deviations and CAPAWork closely with site user and Global stakeholders for Supplier management related matters
QA Raw Material Release and Warehouse oversightSupport incoming material documentation review and release to recommend and confirm Usage Decision (UD) of raw material
Ensure that material document file (MDF) is complete and accurate before disposition of material in SAP
Ensure that system is in place for filing and archival of MDF
Initiate and review deviations/change control/CAPA associated with incoming material releases.
Ensure that all deviations/change controls are closed or assessed for impact on the release of the material prior to release the QA-controlled incoming material
Provide QA oversight to warehouse such as attending warehouse tier, conduction GEMBAs, inspection readiness and warehouse related deviations, CAPAs and change control
Decision Making:Proposals & Recommendations
Propose improvements to work processes, with basic awareness of business requirements.
Deviation investigations and assessments
In addition for QA Executive 2:
Able to provide QA oversight on routine situations independently and complex situations with supervision (deviations, changes, system issues, compliance matters)
Able to manage simple department projects (e.g. continuous improvement) with supervision
Greater awareness of business requirements and to highlight considerations where there is a need for escalation
Skills: Professional At least University basic degree in a Science or Engineering discipline
A good understanding of cGMP regulatory and legal requirements as applied to quality assurance of pharmaceuticals manufacturing
User experiance with SAP will be prefered
Ability in handling and organizing multiple workflows
Ability to facilitate business activities commpatible to international regulatory environment
Ability to communicate effectively within the site organization and across the network
Competencies:Working knowledge of FDA/EU/ICH/WHO as well as all other relevant reuglatory and technical guidelines
Possess Analytical and Quality performance mindset
Demonstrate professional & ethical integrity
Fluency in the English language
Demonstrates sense of urgency
Ability to work both as an individual contributor and as a team player.
Where will I be based? You will be based at one of our manufacturing site in Singapore near Tuas. How can I apply? Why Us? 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 organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030. 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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