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- Melrose Park, Illinois
- USD65,408.87 to USD90,000
- Job Type
- 15 Jan 2023
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The Compliance Officer works with the Compliance Management Team to administer and maintain the Quality Systems in place at the Production Unit from a FDA and global perspective. This function leads teams and projects to identify and correct cGMP inadequacies and ensure a high-level of compliance and Regulatory Audit readiness. The incumbent provides expertise in Deviation investigations, Complaints, Annual Product Review, and helps maintain the compliance of the CAPA system, as well as, reviewing and approving necessary documentation for regulatory correspondence.
Reviews and analyzes manufacturing and laboratory analytical documentation for accuracy and compliance to established procedures
Reviews Deviation investigations and helps define necessary corrective actions to ensure complete, thorough, accurate and timely evaluation of non-conformances and prevention of recurrence
Serves as the compliance SME for all internal audits and supports external and Regulatory Authority audits
Coordinates the collection of information for all Regulatory Requests and assists in the compliance to commitments made to all Regulatory Authorities
Leads internal audit teams to inspect and remediate system and process noncompliance in the plant.
Supports compilation of Annual Product Quality Reviews
Bachelor's Degree in a Scientific or Engineering Discipline is required
Minimum three years experience in the pharmaceutical industry in compliance, technical writing and/or regulatory affairs.
Excellent written and verbal communication skills
Demonstrated experience in problem solving/trouble shooting
High degree of attention to detail
We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program.
Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.
Job Type: Full-time
Pay: $65,408.87 - $90,000.00 per year
Ability to commute/relocate:
Melrose Park, IL 60164: Reliably commute or planning to relocate before starting work (Required)
Microsoft Powerpoint: 3 years (Required)
Work Location: One location
- Job Reference: 876521947-2
- Date Posted: 15 January 2023
- Recruiter: Fresenius Kabi
- Location: Melrose Park, Illinois
- Salary: USD65,408.87 to USD90,000
- Sector: Legal
- Job Type: Permanent