KAILASH CHANDRA
Quality control manager
Almora
Summary
To obtain a responsible and challenging position where my education and work experience will have valuable application and where I can give the organization a new height with my hard work, concentration and sincerity.
Overview
17
17
years of professional experience
2
2
Languages
Work History
Manager Quality Control
RUSAN PHARMA LIMITED
10.2019 - Current
- Company Overview: Certified by SAUMP-Ukraine as per PIC/s, EU, Tanzania FDA, WHO & SHAPRA
- Over all responsibilities of GLP, Exhibit, RM, PM, Finished Goods and Stability section
- To Co-ordinate the auditors in internal/ external and international audits
- GLP Compliances
- To ensure the compliance of 21- CFR part 11
- Change control, Deviation, CAPA Management (QC related)
- Audit Management-QC National and International
- In house calibration of the lab instruments
- Preparation of all the QC SOP related to Chemical, Instrumental and system vise
- Preparation of all the STP and Worksheet
- Coordination with QA in case of Incident, Deviation and OOS
- To organize training to subordinates on GLP and QC SOP
- To prepare the AMC with external party and maintained the documents
- Monitoring the day to day activities of lab in order to establish more robust and consistent system
- To review all the critical and lengthy method of analysis in order to search possibility of improvement and making more compatible
- To impart training on good operating procedure of more sophisticated lab Instruments
- Timely release of Finished Products and in process sample without delay the production
- Selection of laboratory staff
- To approve the COA of Finished Product, Raw Material, Packaging material, Water and etc
- To prepare Analytical method validation protocol and reports
- Other task, as and when required by management
- Certified by SAUMP-Ukraine as per PIC/s, EU, Tanzania FDA, WHO & SHAPRA
Quality Control Sr. Executive
Windlas Healthcare Private Limited
12.2016 - 10.2019
- Company Overview: Certified by USFDA
- Worked in Root cause analysis (RCA) section
- Certified by USFDA
Sr. Executive
Simpex Pharma Pvt. Ltd
06.2015 - 12.2016
- Worked in Quality Control Department
Executive
Windlas Health Care Pvt. Ltd
07.2011 - 06.2015
- Worked in Quality Control Department
Senior Officer
Nector lifescience
07.2010 - 07.2011
- Worked in finished section
Senior Chemist
Matrix Laboratories Ltd
01.2010 - 05.2010
- Worked in finished section
IPCA Labs. Ltd.
04.2008 - 11.2009
Education
Master of Science - Biochemistry
HNB Garhwal University
Srinagar, India 04.2001 - 1 2007
Skills
Team leadership
Job Profile
RUSAN PHARMA, Overall responsibilities of GLP, Exhibit, RM, PM, Finished Goods and Stability section., Coordinate the auditors in internal/external and international audits., Ensure GLP Compliances., Ensure compliance of 21-CFR part 11., Change control, Deviation, CAPA Management (QC related)., Audit Management-QC National and International., In-house calibration of the lab instruments., Preparation of all the QC SOP related to Chemical, Instrumental and system wise., Preparation of all the STP and Worksheet., Coordination with QA in case of Incident, Deviation and OOS., Organize training to subordinates on GLP and QC SOP., Prepare the AMC with external party and maintain the documents., Monitor the day-to-day activities of lab to establish a more robust and consistent system., Review all the critical and lengthy method of analysis to search for possibilities of improvement., Impart training on good operating procedures of more sophisticated lab Instruments., Timely release of Finished Products and in-process samples without delay to production., Selection of laboratory staff., Approve the COA of Finished Product, Raw Material, Packaging material, Water, etc., Prepare Analytical method validation protocol and reports., Other tasks as required by management.
Otherexposureexperience
- Handling & calibration of U.V VISIBLE Spectrophotometer.
- Dissolution apparatus (with Auto sampler).
- Friability apparatus, Disintegration Apparatus, HPLC (Waters alliance) with Empower software & SHIMAZDU (LC2010CHT).
- Knowledge of Laboratory incident, out of specification results, out of calibration, Deviation, CAPA.
Auditfaced
- USFDA
- WHO-GMP
- SHAPRA-SOUTH AFRICA (SAHPRA)
- ANVISA-BRAZIL
- Ukraine (PICs)
- RUSSIA
- TANZANIA FDA
- UGANDA
- KENYA
- NAMIBIA
- EAEU
Trainingcoursesattended
- Good Manufacturing Practices (GMP) training.
- Total Quality Management (TQM) for three days.
- Supply Chain Management (SCM).
- SAP (Systems, Applications and Products).
- EDMS (Electronic Document Management System).
- EQMS (Electronic Quality Management System).
- LIMS (Laboratory Management System).
Majorstrengths
- Self-Motivated.
- Sincere & hard working.
- Ability to give results in stipulated period of time.
- Excellent skills in teamwork.
- Good communication skills.
Fieldsofinterest
- Traveling
- Sport
- Reading Pharma science magazine
Disclaimer
I hereby declare that the above information is true to the best of my knowledge and belief. I hope that you may give me a chance to serve under your keen and loving guidance.
Personal Information
- Father's Name: Mr. P. D. Pandey
- Date of Birth: 04/18/84
- Nationality: Indian
- Marital Status: Married
Timeline
Manager Quality Control
RUSAN PHARMA LIMITED
10.2019 - Current
Quality Control Sr. Executive
Windlas Healthcare Private Limited
12.2016 - 10.2019
Sr. Executive
Simpex Pharma Pvt. Ltd
06.2015 - 12.2016
Executive
Windlas Health Care Pvt. Ltd
07.2011 - 06.2015
Senior Officer
Nector lifescience
07.2010 - 07.2011
Senior Chemist
Matrix Laboratories Ltd
01.2010 - 05.2010
IPCA Labs. Ltd.
04.2008 - 11.2009
Master of Science - Biochemistry
HNB Garhwal University
04.2001 - 1 2007
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