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.
For paper studies, ensures all CRFs and DCFs received are returned for filing in the Document Control Room per the Data Tracking Guidelines for the assigned projects.
Responsible for process validation and cleaning validations and respective documentation. Responsible for Equipment and utilities qualification and periodic validation.
Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.
Post : Team Lead Medical Communications (Scientific Engagements)
Liaise with key partners, including Pfizer Country Organizations, Clinical Development, License Partners, and other stakeholders regarding safety data collection and data reconciliation.
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.
Post : Senior Regulatory Affairs Associate (Labelling)
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