Operations Compliance Improvement Lead (Nights/Weekends)

Job description

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.

We are currently hiring for an Operations Compliance Improvement Lead. In this role, you will support the deviation management for the Operations Departments (Manufacturing and Packaging). To ensure that Operations Departments (Manufacturing and Packaging) remain compliant and up to date on audits, CAPA and CAPA effectiveness.

Key Responsibilities:
• To initiate deviations with relevant problem statements and appropriate attachments to support the site deviation management process.
• To investigate deviations using RCA tools such as fishbone and 5 why analysis and write compliant deviations to pharmaceutical standards.
• To assist the manufacturing and packaging departments with production issues as required.
• To update / create procedures and/or forms as required.
• To run metrics and ensure all CAPA for the manufacturing and packaging departments are completed accurately and on time.
• To develop a process to ensure CAPAs are effective.
• To carry out a periodic review of the CAPA for the departments and present that information to the Operations Support Manager and Department Managers.
• To support the sites Level 1 and Level 2 audits as necessary.

*LI-GSK

Contact information:
You may apply for this position online by selecting the Apply now button.

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Desired profile

Basic qualifications:
High School / GED:

Minimum of 3 years of experience in a regulated production facility.

Experience with technical writing and auditing in a GMP / pharmaceutical environment.

Ability to work Night Shift and flexible to work other shifts as necessary

Preferred qualifications:
• BS Degree in Science, Engineering, or related field.

• Experience in a leadership role in a regulated production facility is preferred.

• Proficient with MS Word and Excel.

• Technical understanding of equipment in a
Manufacturing environment

• Good knowledge of cGMPs.

• Able to manage their time and complete projects on time.

• Proficient with Trackwise preferred.