Senior QA Advisor

An opportunity has arisen for a Senior QA Advisor to join the Quality R&D Supply QA/QP US group within Research and Development. The role is based at Zebulon NC, USA.

About the Zebulon Site

The successful candidate will have a critical role in ensuring quality and compliance of Investigational Medicinal Products used worldwide. In addition, the job holder will have the opportunity to further develop existing expertise and to gain experience within an R&D environment.

It is a fantastic role that offers a wide range of development and progression opportunities depending on your passion.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:

• Review and recommend release of documentation for a range of dosage form batches and finished clinical trial packs of Investigational Medicinal Products in accordance with GMP/GSK requirements.

• Assessment of Quality QMS Records (e.g. Deviations and third party or internal complaints), make recommendations for corrective and preventative actions and to follow up on the implementation of those recommendations.

• Review and Approve GMP documentation, which may include Standard Operating Procedures, Change Controls and other controlled documents from business partner areas such as Clinical Supply Chain packaging operations and logistics

• Provide advice and support to business partner areas relating to quality matters and process improvement.

• Develop and incorporate effective processes and procedures in Product Quality Pharma R&D and may contribute to business processes and procedures outside Product Quality Pharma R&D

• May participate in Audit/assessments as well as multiple projects of high priority including regulatory inspections and high-risk non-compliance issues.

• Participate in or lead improvement initiatives

We are looking for professionals with these required skills to achieve our goals:

• Bachelor's degree or equivalent work experience such as 5+ years in similar position
• Experience of QA review of GMP Manufacturing and/or Packaging Documentation and/or laboratory records of pharmaceutical dosage forms which may include sterile products and/or review and approval of GMP documentation within a Quality Assurance/Quality Control role.
• Experience of knowledge of GMP principles and being a decision maker using this knowledge
• Experience leading or participating in QMS activities (e.g. Quality Deviations, third party/Internal Complaints, Change Controls and inspections/audits and root causing)

If you have the following characteristics, it would be a plus:

• Experience working in high pressure environments where there are likely to be conflicting priorities
• Knowledge of the R&D process, particularly with respect to clinical trials manufacturing and packaging.
• Strong attention to detail
• Good communication skills with the ability to build relationships and trust; and make decisions based on GMP principles.

#LI-GSK

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

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