Gopal Venkat
Analytical Development Leader
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About
Extensive Pharmaceutical Analytical Chemistry Research and Development experience with strong leadership, managerial, technical and team building skills. In-depth knowledge of CMC/FDA, ICH, QA/QC, DEA and regulatory compliance. Excellent communication and interaction with cross-functional project teams.
Diligent and independent individual with in-depth knowledge of laboratory protocols and quality system implementation. Effectively managed FDA and DEA inspections timely evaluated and responded IR, DRL, CRL and 483 observations. Demonstrated management and interpersonal skills to lead a vibrant and productive analytical department bringing high quality/compliance standards in the department.
Instrumental for several ANDA approvals.
Experience
Extensive Pharmaceutical Analytical Chemistry Research and Development experience with strong leadership, managerial, technical and team building skills. In-depth knowledge of CMC/FDA, ICH, QA/QC, DEA and regulatory compliance. Excellent communication and interaction with cross-functional project teams.
Diligent and independent individual with in-depth knowledge of laboratory protocols and quality system implementation. Effectively managed FDA and DEA inspections timely evaluated and responded IR, DRL, CRL and 483 observations. Demonstrated management and interpersonal skills to lead a vibrant and productive analytical department bringing high quality/compliance standards in the department.
Instrumental for several ANDA approvals.
