Vietnam Job Openings
GSK
Quality Control Supervisor
November 28, 2024
Site Name: Vietnam - Ho Chi Minh City
Posted Date: Nov 28 2024
Job Purpose:
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. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
Posted Date: Nov 28 2024
Job Purpose:
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The position will ensure quality operations and systems in the GSP warehouse are in compliance with the rules and regulations of the regulatory agencies (WHO GSP, GDP and part of GMP) and that the GSK policies and procedures are being followed.
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The position will provide support to the QA Manager to ensure product quality compliance through E2E product flow.
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Generates and secure records to comply with regulatory requirements, (GSP, GDP and part of GMP and Internal Quality Standard Operating Procedures) within the organization.
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Perform the management of monitoring program to assure activities of all sections are in compliance with applicable GSP, GDP, part of GMP and GSK policies and LSOPs.
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Achieve and sustain the state of compliance to ensure deliverance of quality products to the customer.
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Generates and secure records to comply with regulatory requirements, (GSP, GDP) and part of GMP and GSK QMS.
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Ensure completion of validation, re-qualification and periodic validation review for GSP warehouses and computer systems.
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Regulation compliance check of incoming goods and make sure right status of received products.
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Decision making to release for sale/quarantine/reject products and repacking materials.
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Verification of irregular goods, quarantined/suspended stock, recalled products.
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Supervise all transaction on quarantined/ rejected stock.
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Verification of returned goods to make sure product quality as requirement of processes. Authorising the return to saleable stock of any returned medicines.
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Coordinate with warehouse for repacking plan. Ensure repacking activities are carried out in line with processes, manufacturer’s instruction and regulation/standard compliance.
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Supervise and implement repacking of products. Ensure that the repacking process is carried out in accordance with the prescribed requirements. Products to the market must have information in accordance with the requirements of the law.
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Verify, approve for results from operation activities (i.e. storage condition monitoring, pest control, device calibration)
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Perform the validation and requalification per GSK requirement regularly in regard to facilities, utilities, equipment, cleaning, transport processes.
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Perform validation activities (i.e. Temp. mapping for storage areas, cold box)
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Provides support for the implementation and/or maintenance of a documentation structure, SOP training and related local processes, enabling common Quality Systems and documents to be used within affiliate, including maintenance of accuracy of quality records, version updates and effectivity, periodic record review, obsoleting and archiving.
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Ensure documentation control (i.e. SOP distribution, training records, batch records) is properly managed with assigned scopes.
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Generate and update controlled documents (e.g., procedures, forms, reports) as needed, to ensure compliance with applicable quality objectives and regulatory requirements.
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Ensure change control/deviation documents related to site activities are verified and well documented.
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Deviation and failure investigation.
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Tracks the shipping complaints associated with the distribution to ensure they are appropriately reported, recorded and resolved on a timely basis.
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Participate in quality incident investigation and Lead or co-ordinate investigations and corrective and preventative action recommendations related to product supply chain.
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Coordinating and performing promptly any recall operations of medicinal products.
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Participate and support audits, follow up post-audit if requested.
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Quality inspection (management of monitoring).
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Internal audit (Independent business monitoring)
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Participate in external compliance audits, regulatory inspections as required.
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Monitor third-party CAPAs.
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Support to achieving GSP, GDP and part of GMP certification, to ensure a compliant GSK Quality Management Systems.
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Perform & support gap analysis and risk assessments on processes and evaluate compliance to relevant GSP, GDP and part of GMP regulations/guidelines & implement/support the implementation of corrective actions, prevent action.
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Perform LSOPs quality training and personnel qualification programs (day to day, routine operational basis)
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Ensures all personnel are trained in GSP, GDP for their own duties, including product identification, the risks of falsified medicines and specific training for products requiring more stringent handling.
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Perform other quality reports when requested.
- Internal/External Customer & Partners Satisfaction
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Build network with cross functions in order to build a transparent and consistent working environment within the company.
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Assist GSK Vietnam build quality culture and quality event
- Training/ skill enhancing
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Participate in training course in My-learning/conducted by local Quality team/Region Quality team/CERPs/SAP/Function LSOPs.
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Ensure quality induction training take place.
- Key Deliverables (Success Measures & KPI’s):
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Maintain GSP Certification and Compliance for operations.
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Maintain GMP Audit Certification and Compliance for operations.
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QMS Compliance
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GSP Warehouse Operations
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LSOPs In place and In use
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E2E Batch release.
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CAPA effectiveness
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Pharmaceutical degree is a must
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At least 7 years at minimum of professional experience in GSP, GDP and GMP and Quality management system.
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Professional experience in MNC for pharmaceutical
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Good communication & inter-personal skills. Ability to support and challenge at the same time senior leaders.
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English: fluent oral & written communication.
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Stakeholder management (internal and external): Strong leadership, mentoring, and interpersonal skills with the ability to interact with personnel at all levels.
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Strong organizational and project execution skills, with to ability to effectively manage multiple tasks, priorities, and deadlines in a fast-paced environment.
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Understanding of and experience in quality assurance systems particularly in the areas of batch release, product incidents, artwork control and performing audits
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Knowledge on effective quality documentation systems.
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Ability to deliver clear communications and good working relationships with peers and management
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Problem-solving skills within a structured process
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Good team player – works well in cross-functional teams
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Works with a spirit of continuous improvement, creatively open to new ideas and methods
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Good general computer literacy with Intermediate skills in Microsoft Word, Excel, Power Point and Outlook
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Proficiency in MS Office/knowledge in SAP or ERP.
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Relationship building & networking capability
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Leadership ability
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Good communication & inter-personal skills. Ability to support and challenge at the same time senior leaders
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. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
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