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 a degree in MSc/M. Pharma/ B. Pharma
Need to have experience with QC or QA of sterile manufacturing dosages
Need to know the GLP or GMP procedures
Roles & responsibilities :
- Should be able to assist and support the manufacturing/packaging staff in detecting and solving compliance errors in real time during manufacturing and packaging operations and Contribute to the completion of complex projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.
- Experience in creating, review and approve deviations and consistently produce quality work and Assist and support the manufacturing/packaging staff in detecting and solving compliance errors in real time during manufacturing and packaging operations.
- Need to ensure that the information and documentation conforms to Pfizer policy and cGMP's. Create, review and approve Good Manufacturing Practices {also cGMP} audit reports.
- Review and approve Manufacturing and Packaging records.
- Corrective Action / Preventative Action Effectiveness, Right First Time (RFT) Improvement projects, Green/Black belt projects etc. as appropriate participation is required.
- Accurately communicate supply, operational needs or Quality Operations (QO) perspectives and escalate issues with potential market or stability impact.
- Ensure that all documents received in the batch release area reviewed for completeness and accuracy.
- Provide Real Time Quality impact assessments and decisions on product and medical device issues, independently.
- Maintain inspection readiness, support inspections from regulatory agencies & customers and improve quality assurance systems.
- Must define appropriate action plans for improvement and follow-up and communicate action closures.
- Quality Risk Management (QRM) assessments activities supporting and that gain approval through Site and Area Quality Operations (QO) Management.