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GlaxoSmithKline Senior QA Executive (Batch Release) in Tuas, Singapore
To perform batch release activities to maintain cGMP compliance in line with GSK and regulatory standards.
Key Responsibilities Area
Interact with various functions to ensure cGMP compliance in batch release related operations.
Provide quality input and assistance in unplanned events investigations, CAPA implementation, SOP reviewing and change control monitoring
Review and approval of the following documentation as assigned:
LSOPs / Checklists
Deviations / Events
OMCL sample management
Complete QA review of the intermediates and/or final adsorbed bulk for suitability to move batch status to "Restricted" where required for batch forward processing.
Complete QA review of the intermediates and/or final adsorbed bulk and take appropriate release / usage decisions.
Collaborate within site and/or inter-site stakeholders to ensure batch release requirement are met.
Technical terms of supply (TTS) management
Report or escalate to Line Manager key progress and issues.
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.
- Comply with company requirement on EHS
Skills, Knowledge and Experience
University degree in relevant Science or Engineering discipline.
At least 4 years of experience in pharmaceutical industry preferred.
In-depth understanding of GMP standard and regulatory requirements of pharmaceutical industry
User experience with SAP preferred
Good Knowledge of FDA / EU/ ICH/ WHO as well as other relevant regulatory and technical guidelines.
Good understanding of regulatory inspection requirement.
Good knowledge of pharmaceutical manufacturing process
Ability to apply optimal quality assurance standards to promote business edge.
Ability to communicate effectively within the site and inter-site organisation and possess good people management skills.
Ability to apply risk management skills adequately
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.
Our goal is to be one of the world’s most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing.
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