Inspection Readiness Lead
Location:
Missouri
Posted:
November 22, 2016
Position Type:
Full Time
Category:
Quality Assurance
Reference:
WD88727
Basic qualifications:
B.S./B.A. degree plus six years relevant experience or equivalent combination of education and experience.

Minimum of 5-8 years experience within the Pharmaceutical / Consumer Healthcare industries, preferably in the capacity of a senior quality specialist or a supervisor.

Preferred qualifications:
Bachelor's degree within a Scientific discipline

Strong understanding of and experience in quality assurance systems particularly in the areas of internal/external and regulatory audits, regulatory filings, deviation investigations, change control, and validation

Strong knowledge of Regulatory requirements pertaining to cGMP

Good knowledge on effective quality documentation systems

Professional written and verbal communication skills

Analytical thought process and good problem solving skills

Team work and people management skills

Good time management skills, with ability to multi-task and work under pressure

Ability to compose clear, concise and scientifically sound reports

Ability to work with a spirit of continuous improvement and innovation, creatively open to new ideas and methods

Strong general computer literacy with Intermediate skills in Microsoft Word, Excel, Power Point and Outlook

Statistical analysis knowledge and capability

Details:
At GlaxoSmithKline, our mission is to improve the quality of human life by enabling people to do more, feel better and live longer. As the world's largest manufacturer of over-the-counter products, reaching more than 1 billion consumers, GSK's Consumer Healthcare business is on an exciting journey. We're passionate about building the world's best fast-moving consumer healthcare company with a focus on quality, backed by science.

Our Consumer Healthcare facility in St. Louis, MO proudly manufactures household names such as TUMS, OsCal, and Citrucel. We're proud of our heritage and success in the St. Louis... and our impact on consumers' lives around the world.

In this role, you will provide support to the site during regulatory inspections from both FDA and other foreign markets. This role will work with all groups at the site to maintain a status of inspection readiness everyday. This position will also support the Site Compliance Manager, QMS Champion and Compliance Team Leader as back-up.

Key Responsibilities
• Responsible for ensure the site is inspection ready everyday by developing a sustainable IR program for the site.
• Responsible for leading a site Inspection readiness team comprised of members of various departments to ensure a robust process is put in place.
• Responsible for creating standard work for the control room during an audit.
• Responsible for creating training for the control room staff on audit responsibilities.
• Responsible for completing all assigned tasks - CAPA, training, etc on time.
• Review and approve site documentation to ensure compliance with regulations, GSK standards and local regulations.
• Responsible for creating training for SMEs (Subject Matter Experts) on how to deal and act in a regulatory inspection.
• Responsible for creating and maintaining site storyboards for critical incidents and processes to be used during an inspection.
• Assists during FDA investigations. This is done by providing all necessary files, review of the files, providing trend information and when necessary responding to FDA questions.
• Perform other duties as assigned.
• Adher to all GSK safety guidelines and procedures.
• May act as backup to the QMS Champion, Compliance Team Leader and/or QA Compliance Manager

*LI-GSK

Contact information:

You may apply for this position online by selecting the Apply now button.
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A little about us:
We are a science-led global healthcare company on a mission to help people to do more, feel better and live longer.

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