Description :
Overview :
The Quality Compliance Auditor will be responsible for scheduling and performing audits of Medicis vendors to assure the methods, facilities and controls used to manufacture, package, process and hold products are in compliance with the Code of Federal Regulations, 21 CFR parts 210, 211, 11 and 820 and product filings as well as ICH and FDA guidance documents and industry standards. The Auditor will prepare audit agendas, comprehensive written reports of audit findings as part of the facility report and follow up on audit responses and effectiveness of corrective actions implemented.
The Quality Compliance auditor will also be responsible for scheduling and performing internal audits of Medicis Headquarters cGMP departments to assure compliance with the Code of Federal Regulations, 21 CFR parts 210, 211, 11 and 820, product filings as well as ICH and FDA guidance documents and industry standards. The Quality Compliance Auditor will prepare audit agendas and comprehensive written reports of audit findings as part of the internal audit function as well as follow up on audit responses and the effectiveness of corrective actions implemented.
In compliance with 21CFR section 820.22 "Quality Audit", the Auditor shall conduct internal audits to assure that the quality system is in compliance with the established system requirements and determine its' effectiveness. Perform re-audits of deficient matters and prepare reports for review by management.
Responsibilities :
Auditing Medicis vendors assures that Medicis is fulfilling its responsibilities to FDA as well as ensuring future business continuity of that vendor. Vendors found to be significantly out of compliance pose a business risk and jeopardize future supply of product. The expected outcome is assurance that vendors are in compliance or new vendors are found as replacement.
Auditing internal cGMP departments at Medicis HQ is also viewed as fulfilling responsibilities to FDA, complying with 21 CFR part 820.22 as well as ensuring future business continuity. Gaps of non-compliance can be rectified prior an FDA inspection.
Assistance with Regulations training further supports the compliance initiative at Medicis HQ as well as taking opportunities to raise awareness of the regulations by assisting departments with audit observation solutions.
Qualifications :
Bachelor's Degree
3-5 years experience
Experience in a Quality Assurance role in pharmaceutical, biologic or medical device products is required
Pharmaceutical chemistry laboratory experience a plus
AA/EEO Employer
