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 Assurance Staff you will be responsible for supporting the local operating company manager to implement and maintain and 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.
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
Execute and deliver quality objectives, quality improvement plan, and trends against the quality key performance indicators to drive continuous improvement
Monitor quality performance and key performance indicators assigned to third parties to ensure quality and compliance issues are identified, communicated, and resolved
Support the local change control process to ensure all planned major changes are effectively and compliantly managed
Perform activities to support the risk management process to ensure effective management, timely reporting, review and escalation of quality risks
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
Support the complaints management process to ensure potential issues are determine quickly, linked to the adverse events, reported, and follow up on product complaints
Liaison with external suppliers for products that are manufactured by contractors to ensure compliance to local registered technical details
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
Work daily to support systems that have an impact on the quality of imported products and the products are in line with the quality management system
Liaison with manufacturing sites to ensure compliance to local registered technical details
Ensure the timely release of imported finished goods deliveries and resolve quality-related issues from deliveries
Communicate with Global Manufacturing Supply sites regarding regional quality as it relates to approval of repacking activities and resolving quality issues with the product supplied
Perform daily support of repacking to ensure batch release orders are compliant and meet regulatory guidelines before distribution and/or re-export
Ensure all product specifications and related documents are maintained and compliant to current registered details
Support Quality Manager in ensuring product storage and distribution performed by third party warehousing and distribution service providers complies with GSK standards
Ensure as appropriate documentation of batch records and retention of samples
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
Bachelor’s degree
2+ years’ experience within the Pharmaceutical/Consumer Healthcare industries
Experience in quality assurance systems particularly in the areas of batch release, repacking, product incidents, artwork control and performing self-inspection
Experience with regulatory requirements pertaining to good manufacturing practices and good documentation practices
Experience working with effective quality documentation systems
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
Previous role as a quality associate or specialist
Good 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 multi-task and work under pressure
Identify areas of continuous improvement and innovative ways of working
Ability to demonstrate flexible thinking
Strong general computer literacy with Intermediate skills in Microsoft Word, Excel, Power Point and Outlook
*LI-GSK
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.
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