Senior Quality Engineer, CMO & NPD
Location: Salt Lake City Utah
Description: Reckitt Benckiser is currently seeking to employ Senior Quality Engineer, CMO & NPD right now, this occupation will be placed in Utah. Further informations about this occupation opportunity kindly read the description below. Senior Quality Engineer, CMO & NPDDescription
This position will work closely with CMOs in collaboration with Quality release team in North America to! ensure that all products supplied by contract manufacturing organizations (CMOs) in North America meet the appropriate standards of quality. Scope includes all Health and Personal Care products. Participate and represent Quality in all local NPD projects that were historically provided by Fort Worth QA organization. Excluding projects lead by Category R&D. Work closely with RB sites manufacturing product for import to US on all matters relating to GMP and FDA Inspections. This position will be located in Salt Lake City, UT.
Responsibilities
Execute and maintain quality management systems, regulatory compliance, quality control laboratory functions, documentation control, quality audit functions, both for imported NDA and monograph products and with contract manufacturers and packagers. This includes assuring that all product specifications and all regulatory requirements have been satisfied prior to the final release of any product into the distribution c! hannel.
Ensure prompt action(s) are taken at requests from! CMOs to resolve non-conformances, deviations, validation, change control, and other process related issues.
Work closely with department management to establish strong links with existing CMOs through regular audits, visits, and resolution of quality issues.
Participate in regular meetings (teleconferences) with CMOs, the Planning, and Supply groups to ensure no disruption of product supply.
Work closely with the Quality Release team based in Harrisburg, PA to ensure that all batches of CMO manufactured product are released according to FDA requirements for sale in the US.
Approve GMP documentation in a timely manner such as change control and validation for CMO products prior to release.
Process and investigate all 3rd party quality complaints including trend analysis, and corrective and preventive actions as deemed appropriate
Participate and work closely with the department management to integrate new CMOs into RB QA process, including initial QA! , audit, approval, and ongoing management.
Hold regular meetings with the CMOs to resolve all audit CAPAs and closely monitor the CMO audit CAPAs through completion.
Create monthly trends on the performance of CMOs for key quality metrics.
Provide weekly reports of progress in CMOs audit CAPAs as appropriate.
Provide monthly trends on CMO complaints and investigations.
Participate in all international, federal, state and local regulatory officials in regards to the manufacture and release of any drug product by Reckitt Benckiser North America.
Work closely with the Quality Release team in Harrisburg, PA for flawless release of imported products and proactively work with manufacturing sites to ensure release.
Collaborate with contract manufacturers by providing support to ensure continued cGMP compliance
Participate in the global API audit program with audits of manufactures based in North America.
Process all complaints involving product ! quality for thorough investigation and appropriate corrective actions. !
Support the of a recall situation for NDA and Monograph and Personal Care Products.
Complete annual reports for CMO commercial products in a timely basis.
Participate in all local NPD activities as required for local brands in conjunction with SSG as needed.
Senior Quality Engineer, CMO & NPDQualifications:
Bachelor's degree in a scientific or technical field such as Chemistry, Chemical Engineering, Industrial Engineering, Mechanical Engineering, or Manufacturing Engineering.
Candidate shall have 5 - 10 years of quality assurance work experience in a Pharmaceutical/Medical device industry
Demonstrated ability to multi-task complex projects in a fast paced environment.
Must have a strong working knowledge of applicable parts of Title 21 of the CFR, ICH guidelines.
Experience using electronic quality management tools such as TrackWise is a PLUS.
Experience with quality tools such as: SPC, Advanced Quality Planning, Co! ntrol Plans, FMEA, Root-Cause Analysis, Six Sigma a PLUS.
Ability to work confidently and effectively with agents of governmental regulatory bodies as well as internal and external customers and suppliers.
Must exhibit excellent communication and facilitation skills, both oral and written.
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If you were eligible to this occupation, please email us your resume, with salary requirements and a resume to Reckitt Benckiser.
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This occupation starts available on: Tue, 27 Aug 2013 09:31:05 GMT