صاحب العمل نشط
حالة تأهب وظيفة
سيتم تحديثك بأحدث تنبيهات الوظائف عبر البريد الإلكترونيحالة تأهب وظيفة
سيتم تحديثك بأحدث تنبيهات الوظائف عبر البريد الإلكترونيWe 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
ADDITIONAL RESPONSIBILITIES:
The candidate MUST have the following skills without which the application will not be reviewed:
The candidate must be able to work collectively in a team-spirit dedicated to attain the highest standards of science and medicine. Candidate should be able to work with a global team across US/India time zones; cultural differences; multi-tasking; results-oriented; experienced in working at small biotech start up environment; good communication skills; highest levels of integrity; and able to deliver results based upon milestones.
EDUCATIONAL REQUIREMENT:
Candidate MUST have the minimum level of Masters (post-graduate) in Pharmacy / Biotechnology / Microbiology / Life Sciences or any other related Biology field) specializing in the areas QC, QA and Regulatory, with focus on GxP compliance, and product release.
MINIMUM YEARS OF EXPERIENCE IN THE AREA:
Candidate must have worked for at least 15 years in the areas of Quality (both QC and QA) with significant experience in implementation of quality management systems in Biologics, Biosimilars or Cell-based product manufacturing company.
دوام كامل