Leena Patel

WORK HISTORY

EDUCATION

ABOUT LEENA PATEL

Experienced Senior Executive with a demonstrated history of working in the pharmaceuticals industry. Skilled in Documentation & Team Building : 1. Review & Approve Drug Development Reports, Specification & MOAs of KSM/In-Process/Intermediate, new product specification and Analytical Procedures for key raw materials, Intermediates and Finished Products, Analytical Method Validation protocols & reports as per defined procedure, LNB, Technical package. Review & Approve Protocols & Reports of Computer Software Validation. To assign protocol & Report no, issue & archive all log books/LNBs/Instrument Usage Log books etc. maintained by departments. To Prepare, Review, Approval & Control of SOPs. To ensure login & timely closure of Lab QMS documents like Change control, Deviation etc. wrt impacting documents by respective department & maintain the log. To Prepare a Vendor Evaluation Report at R&D level in co-ordination with Materials, RA & IPMG Team. To support site Production/QA & QC for providing required documents proactively, avoiding any delay during Technology Transfer. Periodic reviews of different records maintained by the related departments & provide inputs as applicable wrt R&D for system improvement. To Co-ordinate with other interface-departments & locations also and do all Administrative Planning of Department. Co-ordination with the Regulatory Team & various departments for resolving queries. To coordinate with CQA and Site QA with respect to Technology Transfer. To Review & Approve protocols & Reports for Computer Software validation. To Review & Approve Kilo-Lab MBPR/MECR for Development Batches.