Prepares, literature review, abstracts, posters, and slide sets, and Manuscripts sophisticated working from various data sources including clinical study reports, patient profiles, protocols etc.
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.
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