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
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
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
Our values and expectations are at the heart of everything we do and form an important part of our culture.
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
- Operating at pace and agile decision-making – using evidence and applying judgement to balance pace, rigour and risk.
- Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
- Continuously looking for opportunities to learn, build skills and share learning.
- Sustaining energy and well-being.
- Building strong relationships and collaboration, honest and open conversations.
- Budgeting and cost-consciousness.