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Operational Quality Manufacturing Specialist
3 mesi fa
Posted Date: Jun
Are you looking for an opportunity to support a Quality Management team in the day to day operations in a manufacturing environment? If so, this is the role for you.
As Operational Quality Specialist staff you will be responsible for supporting in implementing and maintaining an effective and robust quality management system. You will also perform day to day quality operations to ensure lean and efficient ways of working to meet compliance standards.
We create a place where people can grow, be their best, be safe, and feel welcome, valued, and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme.
We embrace modern work practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work.
Discover more about our company wide benefits and life at GSK on our webpage Life at GSK | GSK
This role will provide YOU the opportunity to lead key activities to progress YOUR career.These responsibilities include some of the following:
- Lead process deviations, ensuring that all investigations are thorough and complete
- Develop local processes to conduct root cause analysis; identify where corrective/preventative actions plans are required and ensure they are effectively implemented, monitored, and closed out
- Elaborate product quality impact assessments for batches involved in product incidents
- Monitor quality performance and key performance indicators assigned to third parties to ensure quality and compliance issues are identified, communicated, and resolved
- Support the Quality Manager to ensure that an effective local product incident process is in place and manage any product quality related issues and train staff as appropriate, and in ensuring product storage and distribution performed by third party warehousing and distribution service providers complies with GSK standards
- Perform activities to support the risk management process to ensure effective management, timely reporting, review and escalation of quality risks
- Ensure all product specifications and related documents are maintained and compliant to current registered details
- Support the local change control process to ensure all planned major changes are effectively and compliantly managed and support the complaints management process to ensure potential issues are determine quickly, linked to the adverse events, reported, and follow up on product complaints
- Ensure as appropriate documentation of batch records and retention of samples
- Bachelor's degree in a science-related field
- Experience in pharmaceutical quality assurance systems, particularly in the area of process deviations coordination (RCA, quality impact assessment, CAPA definition)
- Experience with regulatory requirements pertaining to good manufacturing practices
- Experience working with effective quality documentation systems
- Excellent written and verbal communication skills
- Analytical thinker with good attention to detail and problem-solving skills in a structured process
- Team player with the ability to work in cross-functional teams
- Ability to work under pressure
- Able to identify areas of continuous improvement and innovative ways of working
- Ability to demonstrate flexible thinking
Closing Date for Applications – June 21, 2024
Please take a copy of the Job Description, as this will not be available post closure of the advert.
When applying for this role, please use the 'cover letter' of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.
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.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at US Toll Free) or outside US).
GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
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Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.
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