Maintaining detailed records of studies as per FDA and other required guidelines, including things such as drug administration and subject specific case report forms.
PAREXEL has supported the Bio-Tech and Pharmaceutical industries in helping the development of new drugs and treatments on a global basis. As a leading global biopharmaceutical service provider, they supply knowledge-based contract research, medical communications and consulting services across a broad range of therapeutic areas to the worldwide pharmaceutical, biotechnology and medical device industries.
Expertise of Finish goods testing. Stability, RM Analytical Method Validation, Dissolution, HPLC, PMQC and knowledge of handle other sophisticated instruments like GC, XRD, ICPMS, LCMS.
Responsible for process validation and cleaning validations and respective documentation. Responsible for Equipment and utilities qualification and periodic validation.
Liaise with key partners, including Pfizer Country Organizations, Clinical Development, License Partners, and other stakeholders regarding safety data collection and data reconciliation.
M.Pharm/B.Pharm/M.Sc/B.Sc; IPQA/APQR/Validation and Qualification; Handling Change Control/ CAPA/ Deviation/ Investigation and Audit Management; Issuance and Retrieval of GMP Document
Ipca is a fully integrated, rapidly growing Indian pharmaceutical company with a strong thrust on export. Ipca'a API and Formulation produced at world class manufacturing facilities are approved by leading drug regulatory authorised including the USFDA.
To provide scientific support to analysts at bench level for developing & qualifying methods required for product Analytics. Execution of critical experiments for specific deliverables.
Hetero Drugs is an Indian pharmaceutical company and the worlds largest producer of anti-retroviral drugs. Hetero business includes APIs, generics, biosimilars, custom pharmaceutical services, and branded generics.