Quality Compliance Specialist – External Operations Coordinator

Title: Quality Compliance Specialist – External Operations Coordinator
Source: MyJobHelper
Category: Quality, Long-Term
Posted On: 2015-03-09T00:00:00.000-04:00
Description:
Overview:



Quality Compliance Specialist – External Operations Coordinator is responsible for assuring compliance to all regulatory requirements through the development and implementation of an effective Risk Management program, manage data for reporting to corporate and third party entities and maintain metrics dashboard for internal reporting. This position will report to Senior Manager, Quality Compliance.






Responsibilities:



v Organizing and managing information and data transfer between West-Ward and Hikma/Hikma International Pharmaceuticals (HIP) corporate entities.


v Coordinates and manages Hikma/HIP reporting program to include monthly meetings and updates, quarterly compliance updates, ad-hoc requests.


v Reviewing Quality and Technical Agreements for Manufacturer/Suppliers and Third party contract (Service providers, External labs…).


v Manage Site Gap Analysis activities on behalf of West Ward internal and Hikma Corporate for assessing industry and companywide regulatory observations, issues and/or trends.


v Support the Site internal and external metrics reporting dashboard.


v Serving as lead coordinator for external data requests, inclusive of West Ward Third party entities.


v Assist in data gathering and preparation for FDA inspection and associated Regulatory Agencies inspections.


v Participates in the Internal Audit Program and identifies opportunities to refine processes and practices where possible to improve the overall value of the QMS


v Assists Quality Compliance team members as a back-up resource.


v Serve as the Quality representative on cross-functional and multi-site teams, as assigned.






Qualifications:



To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.


Bachelors degree in Chemistry, Biology, Pharmacy, Engineering or related scientific discipline.Strong knowledge of quality and packaging issuesMinimum of 3-5 years of Pharmaceutical or related experience, preferably in FDA regulated industry.Experience with the application of FDA and/or ISO Quality System Requirements.Evidence of a strong work ethic, demonstrated leadership, and an ability to quickly and effectively learn new skills is required.Demonstrated working knowledge of cGMP and applicable regulatory requirements.Strong technical writing and oral communication skills.




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