job details
We are looking for a well-established expert in the area of Quality, with emphasis on Quality Control and with strong scientific credentials who are aligned with our noble mission. The candidate should be driven to attain the highest standards of success with integrity.
The role of the Head of Quality will be an integral part of our organization. This contributor should apply extensive organizational skills and knowledge both as an individual and as part of a team, to lead both QC and QA departments of the organization as well as meeting regulatory requirements (in terms of standards and regulations) and QC requirements (in terms of good engineering). The Head of Quality role is expected to provide significant guidance as well as hands on support in the development of new documents, procedures, and changes to existing procedures, processes, plans, and other quality system documentation. The successful candidate will be required to support the creation of regulatory submissions [CMC package for IND submission, FDA inspection of the manufacturing facility etc) and/or updating documents and procedures as well as actively participate in the creation, implementation and continuous improvement of the quality system including developing, maintaining and reporting quality system metrics. The Head of Quality role would manage changes to documentation/PLM(Product lifecycle management) system. New documents and document changes are required to be entered into the documentation system, approvals are obtained, and documents are distributed in a controlled manner.
Applicable data/records are to be processed into a documentation system on a daily basis and reports are generated. All documents must be stored and organized to facilitate efficient and timely retrieval via the documentation system MAJOR RESPONSIBILITIES:
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