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
Qualification required : B. Pharma or M. Pharma or MSc
Experience required for the Job : 10-12 years
Candidate need to have experience with the manufacturing/ QA / or MQA in injectable facility
Need to have good communication skills and able to perform and write the technical reports.
Able to provide the solutions for challenging and bigger tasks
Need to make decisions and provide the quality culture in the department.
Roles
In-depth knowledge of vial/ampoule washing, solution preparation, depyrogenation, filling and capping.
Sound knowledge and handling the investigations and apply relevant and necessary actions/systems to ensure appropriate levels of compliance.
Candidate is Responsible for leading a team of qualified MQA .
Able to Manges own time to meet forecasts, objectives, and plans resources requirements (People, financial and technology) for projects across department.
Required to deliver the goals and objectives for the quality assurance team to obtain maximum efficacy for department including delivery to cost saving initiatives.
Should be Responsible for ensuring operating state of cGMP compliance in manufacturing operations.
Able to take care and Mange and coordinate all quality functions through Pfizer quality systems.
Understand and handle the procedures and standards, manufacturing policies, confirm to pre-defined regulatory/ site standards/specifications and corporate standards.