Durham, NC 27712
Full-time

Full Job Description

Job Description

Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

We are seeking a Growth and Improvement minded Manufacturing Quality Assurance Associate Specialist that can help drive our Strategic Operating Priorities.

Invent | Pursue the Most Promising Internal and External Science to Address Significant Unmet Medical Needs

Execute | Prioritize Resources Behind Our Key Growth Drivers (Oncology, Vaccines, Select Specialty Areas, Animal Health) While Optimizing Our Base Business)

Adapt | Develop Our People, Culture and Business Model to Evolve with a Dynamic Landscape

Diverse Talent | We are committed to providing an inclusive and welcoming environment with supporting leadership behaviors because having a high-performing, engaged workforce is critical to our ability to deliver innovative solutions to patients and customers around the world

Values and Standards | Our Steadfast Commitment to Our Values and Standards will Continue to Guide Us as We Take on New Challenges and Will Always be Fundamental to Our Success – They are a Competitive Advantage for Us

India

Job Description :
Site Name: India - Maharashtra - Nashik Site Posted Date: Jul 5 2022 Ready to help shape the future of healthcare 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. Responsibilities- . The incumbent is accountable & responsible for Review of Batch documents & Batch release in accordance with GSK QMS & applicable regulatory requirements and acts as the first contact point for any Quality issues in area of operation. . Ensures compliance and inspection readiness . Ensures release of bulk and finished products, meeting the statutory and QMS requirements, to market . BMR, BPR and analytical reports review and subsequent compliance review, PPA - Trending and release for finished products with performing transactions in dMERP (SAP) system. . Handling of dMERP (SAP) system related to batch release and other QA transactions to enable batch release process is followed as per SOP with status tracking & communications. . Ensures that the manufacturing & packing operations on shop floor are in compliance with regulatory and QMS requirements . Ensures support provided for timely compliance to all audit observations in the area. .

Durham, NC 27712

Full Job Description

Job Description

Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

Our Company is expanding its global (HPV) vaccine production network by investing $650 million and adding a 225,000-square-foot building within the footprint of the Maurice R. Hilleman Center for Vaccine Manufacturing in Durham, NC. The new facility will be used to produce the bulk active ingredient for the HPV vaccine, comprised of fermentation, microfiltration/ultrafiltration, and chromatography steps. Approximately 614,000 people are diagnosed with certain HPV-related cancers each year. Our Company manufactures the two HPV vaccines that are predominantly utilized to eradicate these cancers globally. In recent years, countries around the world have enacted new or expanded HPV vaccination programs, which has created an unprecedented increase in global demand. The manufacturing facility in Durham will play a critical role in the network of plants that produce life-saving medicines and vaccines, including our HPV vaccines.

The Quality Specialist provides expertise in the coordination of resources and equipment pertaining to qualification/validation activities supporting the HPV expansion facility.

GENERAL PROFILE:

Position will initially be M-F first shift transitioning to rotational including holidays. Flexibility to work night shift is required.

Ability to work independently and as a member of a team.

Contributes to the performance and results of the expansion project.

Adapts plans and priorities to address resource and operational challenges.

Decisions are guided by policies, procedures and/or business plans and aligns with management.

Provides quality guidance to employees, colleagues or clients.

Anticipates and interprets client and/or customer needs to identify solutions.

Job Description :

India - Maharashtra - Nashik Site Posted Date: Jul 5 2022 Ready to help shape the future of healthcare 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.

Job Description :
Site Name: India - Maharashtra - Nashik Site Posted Date: Jul 5 2022 Ready to help shape the future of healthcare 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. Responsibilities- . The incumbent is accountable & responsible for Review of Batch documents & Batch release in accordance with GSK QMS & applicable regulatory requirements and acts as the first contact point for any Quality issues in area of operation. . Ensures compliance and inspection readiness . Ensures release of bulk and finished products, meeting the statutory and QMS requirements, to market . BMR, BPR and analytical reports review and subsequent compliance review, PPA - Trending and release for finished products with performing transactions in dMERP (SAP) system. . Handling of dMERP (SAP) system related to batch release and other QA transactions to enable batch release process is followed as per SOP with status tracking & communications. . Ensures that the manufacturing & packing operations on shop floor are in compliance with regulatory and QMS requirements .