Rimple Sharma
Fähigkeiten und Kenntnisse
Werdegang
Berufserfahrung von Rimple Sharma
- 2 Jahre und 4 Monate, Juni 2016 - Sep. 2018
Regulatory Information Management, Process Improvement & Excellence
Novartis, India
Global Regulatory compliance.
- 8 Monate, Okt. 2015 - Mai 2016
Pharmacovigilance (Short Contract Job)
Tech Mahindra
• Review of source documents such as AEM forms mapped, unmapped cases and spreadsheets received from the reporters. • Completion of data entry from source documents provided including a narrative, complete the custodial review detailing the adverse events, selection and coding of event terms, concomitant medications and medical history against source documents. • Evaluates consistency, completeness, accuracy of safety database, tracking database and source documents entry forms.
- 9 Monate, Mai 2014 - Jan. 2015
Pharma Quality Assurance
M/s Indoco Remedies Limited, Baddi, India
• Review of technical documents like specifications, standard test procedures (STPs), batch manufacturing records (BMRs), Certificate of Analysis(COAs) for adequacy. • Handling of Market complaints.Implementation of CAPA in response to customer complaints. • Coordination with regulatory affairs department for dossier related documents, samples, COPPs, additional product approvals and loan license documentations. • Handling of change control and deviations.
- 2 Jahre, Juni 2012 - Mai 2014
Pharma Quality Assurance
M/s FDC Limited, India
• Document Issuance (BMRs, BPRs, Log books, Protocols, SOPs and specifications). • Preparation of Annual Product Quality Reviews (APQRs). • Training coordination as per Annual Training Plan. • Handling of Vendor assessment documents. • Handling of change control and deviation.
Ausbildung von Rimple Sharma
- 5 Monate, Sep. 2020 - Jan. 2021
German as a foreign language
Telc
- 2 Jahre und 2 Monate, Juli 2009 - Aug. 2011
M. Pharmacy (Pharmaceutics)
Guru Jambheshwar University of Science & Technology (GJU), Hisar, Haryana
Pharmaceutics
- 1 Jahr, Juli 2005 - Juni 2006
B. Pharmacy
Maharishi Dayanand University (MDU), Rohtak, Haryana
Sprachen
Englisch
Fließend
Deutsch
Gut
Hebräisch
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