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[[Quality Assurance GMP Auditor and Consultant]]
Location: [[Lafayette, IN]]
Career Level: [[15+]]
Legal Entity: [[Evonik Corporation ]]
Business Line: [[Health Care]]
What we offer
You will work on exciting and challenging topics together with a team in an ultra-modern, innovative and creative environment. Intensive on-the-job training with expert colleagues guarantees you will quickly become familiar with your duties and perform them independently. Performance related pay and the opportunity for personal and professional development are of course part of the package. Since 2009 Evonik Industries AG has been certified as a family-friendly company by the German Hertie Foundation.
Click here to learn more about Evonik from our employees
Manages/coordinates the process for internal GMP audits for the business line Health Care. Oversees the supplier audits program for the business line Health Care. Provides support to business line Health Care sites in preparations for, and participation in, regulatory agency inspections. Contributes to improvements in quality systems and quality systems execution.
Create Annual Internal NC-HC Audit Plan.
Perform all tasks and activities associated with any individual internal audit cycle (announcement; agenda; consultation with site Quality management; audit execution; report writing; participation in CAPA plan review and approval).
Write annual summary report for NC-HC internal audits.
Conducts the Site BL GMP audits for Evonik Health Care.
Coordinates supplier audit cycle beginning in Q4 for the subsequent calendar year by requesting each site's supplier audit plan.
Compiles all NC-HC supplier audits into a single table, accessible to each person responsible for his/her site's audit plan; assesses potential for distributing audit responsibilities to a) sites in a more convenient geographic location; b) to 3rd party contract audit services.
Sends quarterly reminders to sites to update site lists on the global server.
Write annual summary report for NC-HC supplier audits.
Respond to questions/issues from sites as needed.
On an as-requested basis, provide inspection readiness and preparation support in advance of regulatory inspections. This can include any of the following activities: Conduct mock inspection/interview exercises; provide feedback during and after facility walkthroughs; provide feedback on subject matter experts' topic overview presentations; review pre-inspection request list documents to ensure documents are relevant and complete; discuss "Do's and Don'ts" of regulatory inspection interactions; provide encouragement and build confidence.
On an as-requested basis, provide support during a regulatory agency inspection. Support activities can include any of the following: Note taking; document checking; listen for potential translation difficulties during the question-and-answer process; provide input to the site's preparation and strategy for the following inspection day; provide summary of key learning points and "near misses".
BS degree in Chemistry, Engineering, or related field; MS degree preferred.
At least 15 years in quality/technical support role(s) in the pharmaceutical industry with demonstrated knowledge and/or experience with cGMPs and data documentation.
Knowledge / expertise in the following areas: final dosage form manufacturing, aseptic /sterile processing, cleanroom requirements/regulations
A minimum of 5 years of auditing experience in a full-time auditing role is required.
Availability and willingness for global travel, which can include travel periods of 2-3 weeks at a time.
Intermediate to advanced computer skills including Microsoft Word, Excel, Power Point.
Strong grammar/composition/editing skills.
Effective communication and interpersonal skills with the ability to work with multiple levels within the organization.
Capability to deal with conflict or differences of opinion in a constructive manner.
Organization and prioritization skills to complete multiple, complex tasks on time
Self-directed, self-managed, reliable, and capable of success with minimal supervision.
Project management skills that result in completing assigned tasks on time and encompass an ability to prioritize in an environment of competing demands.
To ensure the fastest process of your application and to protect the environment, please apply online via our careers portal at https://careers.evonik.com.
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Please note that Evonik will not accept any unsolicited application documents sent by staffing firms. Evonik works in conjunction with preferred service providers and will not pay any fee to staffing firms in the absence of an appropriate framework agreement. Should Evonik receive a candidate profile from a staffing firm with which it has no framework agreement, and should this candidate subsequently be considered in the recruitment process or offered employment, no claims from the staffing firm will be entertained in this regard.