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
For Associate in Quality assurance
Qualification : Bachelors degree with sound knowledge in GMP and need to have good communication and oral skills
Candidate need to have experience in manufacturing site and able to handle the deviations and manage the production batch records and investigations
Role
Handling the Acceptable Quality level sampling, Inspection and record the results in Batch records for all products
Need to have knowledge and hands on experience in reviewing EBR and assessing the impact of AMPs exceptions with technical support/inputs from Sr. Specialist or Supervisor.
Making the timely random process checks for Terminal Sterilization, Visual Inspection and Packaging
Able to perform the Daily walkthroughs and report observations to the Supervisor.
Identifying the Equipment breakdown assessments w.r.t to Product Quality and patient safety with technical support/inputs from Sr. Specialist or Supervisor.
Ale to perform the Review of Batch reports, and Equipment audit trails
Batch start-up and end activities viz. sensor challenge tests, recipe review etc to be performed .
For Team Lead - Manufacturing
Experience : 3+ years in Manufacturing with sound knowledge in up stream and downstream manufacturing process
Able to manage people and need to have excellent leadership and inter personal skills
Qualification : Masters degree and with relevant pharma experience
Role
Need to support the shift colleagues in their individual developmental plan
Need to perform the quality checks and process conformation
Able to handle the Process through six sigma and processing the activities through IMEX standard elements
Need to attend the required trainings and impart the same to the required colleagues in the department