Years of Professional Pharmaceuticals Industry Experience
SANDIP KUMAR NATH
Sr. Officer II At Quality Assurance Department
Kasba, Kolkata,West Bengal
Summary
OBJECTIVES: To secure a challenging role in a professional environment, utilizing my educational background, strong work ethic, and willingness to take on new responsibilities to contribute to the success of the company.
To ensure implementation and maintenance of Quality Management System elements at site. To ensure the improvement objectives identified during quality metrics presentations are effectively tracked, implemented and the submission of quality metrics data to QA Head and management on time.
Worked as IPQA and Currently working in Quality Management System
Review of routine log books. Monitoring of Day to Day activity. Experienced in record online entries like Batch Packing record and log book entries and Daily Balance calibration and verification sheet entries and Monthly Calibrations of Balances and Daily check list entries of machineries. Preparation of APQR, Market Complain, BMR, Handling Of Deviation, Change Control. Licensing Documentation Preparation for local WHO and COPP Preparation
To evaluate the efficiency of the department and ensure that required training imparted to cross functional team members. To review/approve and ensure that the Change Control Management (CCM) & Document Change Request (DCR) are assessed and closed as per Standard Operating Procedure.
To conduct the site management review & NCR, OOS/OOT/OOL, Change Control review meeting on time. To support in external & internal audit at site. To provide audit observation related to compliance of QMS elements. To provide notification to key management teammates for critical quality impacting QMS elements.
Overview
8
8
4
4
Years of QMS Experience
Work History
Sr Officer II
Macleods Pharmaceuticals Ltd,
Gangtok, Sikkim
06.2016 - Current
- Directed work of Quality Management System and In-Process Quality Assurance (IPQA), monitoring quality, compliance and productivity.
- Conceived and oversaw Introduction of SAP HANA In Macleods Pharmaceuticals Ltd, Unit IX special projects.
- Produced reports each month outlining Quality metrics and Monthly Reports and APQR Data.
- Set objectives for Master Preparations (BMR/ BPR, Price List, APQR etc) and Handling of Out of Trend (OOT), Out of limit (OOL), Laboratory Investigation Report (LIR), Change Control and Deviationestablished performance benchmarks.
- Managed large-scale projects and introduced new systems, tools, and processes to achieve challenging objectives.
Trainee
Dr Reddy Laboratories, HP
Khol
11.2013 - 12.2013
- For 30 Days in Production, Quality Control, Packaging, Quality Assurance
Education
10th-Matric - Mathematics, Science, English
Kendriya Vidyalaya Ballygunge
Kolkata, West Bengal 04.2007 - 03.2008
Master in Pharmacy (M. Pharm) - Pharmaceutical Sciences (Pharmaceutics)
NSHM Knowledge Campus, MKAUT
Kolkata, West Bengal 07.2014 - 07.2016
Bachelor of Pharmacy, (B.Pharm) - Pharmaceutical Sciences
Maharishi Arvind Institute of Pharmacy, RUHS
Jaipur, Rajasthan 08.2010 - 06.2014
12th- Graduation - Physics, Chemistry, Biology
Vikas Educational Institute, CBSE
04.2009 - 03.2010
Skills
Certified ISO 9001:2015 - Quality Management System (QMS) – Alison
Certified SAP (Systems, Applications, Products In Data Processing) In Pharmaceutical Industry – Pharma State Academy
Certification of ALCOA , Change Control, Deviation, Cleaning Validation – Pharma State Academy
Microsoft Office Quality Risk Management SAP Quality Management (QM) Standard Operating Procedure (SOP) Good Manufacturing Practice (GMP) Corrective and Preventive Action (CAPA) Laboratory Information Management System (LIMS) Hazard Analysis and Critical Control Points (HACCP) TrackWise Microsoft Excel Laboratory Information Management System (LIMS)
Accomplishments
- Microsoft Office (Microsoft Excel & Microsoft Word)
- Quality Risk Management
- SAP Quality Management (QM)
- Standard Operating Procedure (SOP)
- Good Manufacturing Practice (GMP)
- Corrective and Preventive Action (CAPA)
- Laboratory Information Management System (LIMS)
- Hazard Analysis and Critical Control Points (HACCP)
- Certified ISO 9001:2015 - Quality Management System (QMS) – Alison
- Certified SAP (Systems, Applications, Products In Data Processing) In Pharmaceutical Industry – Pharma State Academy
- Certification of ALCOA , Change Control, Deviation, Cleaning Validation – Pharma State Academy.
Contact Details
Mob: +917059940531, +918240888767
E-mail: successandsandip@outlook.com
Linkedin: https://www.linkedin.com/in/sandip-nath-b5a02b7b/
Profile: https://bold.pro/my/sandipkumar-nath-231106160816
Timeline
Sr Officer II
Macleods Pharmaceuticals Ltd,
06.2016 - Current
Master in Pharmacy (M. Pharm) - Pharmaceutical Sciences (Pharmaceutics)
NSHM Knowledge Campus, MKAUT
07.2014 - 07.2016
Trainee
Dr Reddy Laboratories, HP
11.2013 - 12.2013
Bachelor of Pharmacy, (B.Pharm) - Pharmaceutical Sciences
Maharishi Arvind Institute of Pharmacy, RUHS
08.2010 - 06.2014
12th- Graduation - Physics, Chemistry, Biology
Vikas Educational Institute, CBSE
04.2009 - 03.2010
10th-Matric - Mathematics, Science, English
Kendriya Vidyalaya Ballygunge
04.2007 - 03.2008