• Gender: Male
• Age: 40
• Designation: Q.C. & Q.A. Officer
• Highest Education Level: Masters - Degree
• Preferred Country: India
• Work Experience: 16.6 Year(s)

Education

MBA or CPGDBA (Operation Management) From SCDL Pune.
B.Sc. (Medical Stream) From HP University Shimla.

Skill Sets

Tally Accountant Course (TFAP & TCP).

Computer Skills
Better knowledge of Window XP, Window Vista, Window 7, Window 8 and
Window 10.
Knowledge of MS office, PDF, Digital Signature on PDF files, Email, Internet and
SAP software.

Work Experience

Quality Control & Quality Assurance Officer (Q.C. & Q.A.).
From Oct.2009 to Till Date
Company profile- leading plastic packaging solution provider in the global pharma space.

Chemical Analyst.
From Nov. 2008 to Oct. 2009
Company profile- Steel Company

Job profile-
Sampling and Analysis of incoming (Raw material & packing material), Outgoing
(Finished Goods) and in process material.
Daily calibration of weighing balance, half yearly calibration of Bursting Strength
Tester and overall calibration of all equipment’s, instruments, gauges, voltmeter,
ampere meter, PID controller, counting sensor, hygrometers and energy meters etc.
once in a year.
Maintain daily production and rejection data of every machine in excel sheet.
Issuing of Batch Manufacturing Record (BMR), Batch Packing Record (BPR) and
analytical Test Reports (ATR) for each batch.
Issuing of Item code wise material specifications and standard testing procedure
specifications of packing material, raw material and finished products.
Maintaining records of validation and qualification of new products and machines.
Maintaining records of area qualification, AHU qualification and validation,
Temperature and Relative humidity monitoring, microbial bioload analysis etc. once
in a year.
Maintaining record and performing the USP test for each product once in a year.
Prepare SOP’s, Site Master File etc. and maintain the record of revision.
Handling of customer complaints by making of RCA, FMEA then investigation reports
and after that close the complaint by making Corrective Action and Preventive Action
(CAPA). And handle the customer complaint trend analysis.
Handling of training activities and training schedule.
Maintain and update the US Drug Master File (US DMF) after each & every change.
Maintain the records of each and every change control.
Prepare the required documents such as Comparison reports of existing and
proposed product, USP test reports, cavity wise observation report, TSE and BSE
certificate, 21 CFR approval letter, TDS, COA, COC, LOA, regulatory certificates of
Material of construction (MOC) etc. for approval of new products.
Analyze and reconcile the BMR, BPR and ATR records before batch release.
Handle the activities of ISO 9001:2015 and GMP certifications.
Handle the auditor’s activities and queries during audit and prepare compliance
report.
Organize self-inspection audits twice in a year for each department.
KNOWLEDGE OF QUALITY EQUIPMENT’S
Better knowledge of handling quality equipment’s like as Vernier caliper, Height Gauge,
Micron Screw Gauge, Magna Mike Hall effect thickness Gauge, Bursting Strength Tester,
Melt Flow Index (MFI) Tester, ESCR tester, Top Load tester, Heat Induction Sealing
Machine, Leak or Vacuum Tester, Universal Tensile Strength testing machine, Torque tester
etc.

Professional Skills
Managed the day to day calendar for Quality department.
Received and screened a high volume of internal and external communications,
including email and post.
Created and maintained spreadsheets using advanced excel functions and
calculations to develop reports and lists.
Created power point presentation used for quality development.
Created weekly and monthly reports with presentation.
Knowledge of different types of packaging material, plastic materials and plastic
processes.