About the Company :
One of the major contributor of medicines globally ranking in top 10 pharma companies. The industry equipped with more than 1500 scientists with more than 5 million testing labs globally and over 36 clinical trials before the first perception. In the area of biotechnological medicine with 25000 clinical researchers testing every day world wide.
The company has located its head quarters in New York with the rank 57 in fortune 500 companies, founded in 1849, which is 170 years ago. Form have joint ventures with GSK and Mylan for improving the quality of medicines.
Large portfolio including branded and generics with products listed from A to Z. Applies rare diseases research to unveil the new therapy treatment, more than 30 million people in USA and 350 million globally uses the medicines for rare disease treatments. Several hematological and neurological rare disease therapies are in research phase. Gene therapy is one of the promising and rapidly developing portfolio in the companies profile, placing genetically corrected copies to patients cells. Having collaboration with Spark therapeutics investigating SPK-9001. As a snapshot 35 projects are in Phase 1, 34 are being in phase 2, 23 in phase 3, 9 went for registration with a total of 101 (metrics as of July 2019)
Constantly providing medicines in the areas of Hospital (anti infectives), oncology, anti inflammatory, oncology, rare diseases, biosimilars, vaccines and new molecular entities.
Partnering in social responsibility by delivering medicines in remote areas and uplifting the needed areas.
About the Job :
Experience : 1-3 years with fundamental knowledge in Quality assurance
Roles & responsibility :
Candidate need to aid in updating corresponding departmental SOP and training materials as needed in accordance with global procedures and processes, as requested and need to Process Master Data updates for Change Controls and document updates.
Required to organize own work to meet project task deadlines and Create new Master Data and process changes to existing Master Data of varying technical complexity.
Expertise with the collaboration with site and global colleagues on assigned team to ensure completion of projects in a timely manner and able to aid in interfacing with site personnel on integration of sample management and electronic system processes to ensure optimal laboratory operations.
Able to contribute to the completion of project tasks and/or milestones and required to provide troubleshooting expertise and support for business unit activities and end users including instrument interfaces in conjunction with the IT Department.
Mingle and support to the team member in all the times.
Provide guidance and Quality oversight of the validation of Automated Systems (Engineering, Manufacturing and Laboratory Equipment and Information Technology) ensuring compliance to applicable regulations.
Required to provide the hands-on, individual and group training(s) as needed for all user levels and develop training modules/protocols/walk-through guides accordingly.