Hirenkumar Lad

Motivated Section Head with 13 years of experience juggling multiple priorities to keep company running smoothly. Communicative team leader possessing outstanding time management and documentation abilities. Polished in overseeing employee performance and guiding and motivating new talent.

• New QC laboratory setup with all Documentation.
• Successfully faced Regulatory Audits (USFDA, EDQM & WHO) and other customer audits.
• N.C.C. - “B” Certificate & ”C” Certificate With The Post of Senior under officer.

• Good knowledge of GMP and Quality management system.
• Excellent knowledge of preparation and review of Standard Operating Procedures involved in Pharmaceutical industries.
• Working under the stringent conditions like GMP and ICH Guidelines.

• Attending training program as “Chromeleone software ” at Mumbai.
• Attending training program as “ISO 14001:2015 and OHSAS 18001:2007” at vapi given by Q Factor consulting Pvt. Ltd.

• Date of Birth: 10-08-1991
• Gender: Male
• Nationality: Indian
• Marital Status: Married

• Planning and execution of work in Quality Control Department (FG – Section, GLP -Section) to reach management targets.
• Trouble shootings of Instruments and Equipments.
• Review of all documents related to Validation Batches, Qualification, Preventive maintenance and calibration of all Q.C Instruments.
• Planning and documentation of Analyst qualification.
• Responsible for System backup/archival of instruments. Investigation of Incident , OOS and OOT results in Track-Wise.
• Knowledge of Method Validation.
• Knowledge of 21 CFR part 11.
• Management of work for raw material, Intermediate and finish goods sampling, analysis, documentation and Data management.
• To prepare SOP (Standard Operating Procedure), STP Standard Test Procedure), Protocols and Reports.

• HPLC – (Make: Agilent, Shimadzu and Thermo with Chromoleon Software Version 6.8, 7.2 software.)
• UV Spectrophotometer - (Make: Shimadzu UV-1700 ,1800 and 1900 with Lab Solution Software).
• Potentiometer - (Make: Metrohm 905 Titrano with tiamo software).
• FTIR - (Make: Shimadzu with Lab Solution Software)
• Karl Fischer apparatus- (Make: Metrohm 890 KFT with Tiamo software).

• English
• Hindi
• Gujarati

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