Tapas Kumar Bishoyi
Ankleswar
Summary
Team Leader experienced in directing activities of workgroups. Develops strategies, provides training, sets goals and obtains team feedback. Excellent interpersonal and communication skills. Big picture focus with excellence in communicating goals and vision to succeed. Problem solver, networker and consensus builder. Successful background matching employees with roles for maximum performance. Proactive and hardworking individual focused on continuous operational improvement.
Overview
14
14
years of professional experience
Work History
Asst. Manager
J.B. Chemical & Pharmaceutical
09.2021 - Current
- Responsible to initiate the change control, OOS, OOT & Deviation in Track wise system, review and closing activity within time line.
- Investigation of Deviation, OOS and OOT by using fish bone diagram, five why technique etc.
- Having an experience to prepare the deviation, OOS and OOT report and provide the CAPA based on successfully investigation.
- To prepare the validation protocol and after execution the batches, prepare the validation report with Data compilation and validation recommendation with conclusion.
- Familiar with cGMP requirements, Data Integrity, Batch release process, shop floor operation in API bulk drug manufacturing.
- Responsible to review of online documentation, Pharma area practices, Production SOP Compliances, Investigation activities of deviation, OOS and OOT.
- Responsible for find out the GAP analysis in SOP (s) and batch manufacturing record and implement the same.
- To ensure the Documentation and records shall be maintained as per ICH-Q7 (GMP/cGMP) requirements.
- To ensure the Validation (Process Validation, Drying Validation, Micronization Validation & Blending Validation.)
- Internal & External Audit compliance.
Sr. Executive
Raks Pharma, Amneal Pharma
06.2021 - 09.2021
- Aligned organizational objectives with company mission to increase business growth and integrate work strategies.
- Established team priorities, maintained schedules and monitored performance.
- Assisted in organizing and overseeing assignments to drive operational excellence.
- Opened and closed location and monitored shift changes to uphold successful operations strategies and maximize business success.
GMP Asst. Manager
Zydus Cadila Healthcare Ltd
08.2015 - 06.2021
- Provide training to soft floor chemist for SOP, completion of SOP’s training of new Joiner and prepare Job description after discussion with HOD.
- Preparation of Batch manufacturing record i.e. Revision of BMR, BMR revision based on PD lab / R&D report, BMR prepare based on New process provided by R&D.
- To initiate change control, preparation of draft documents (Existing and proposed changes) of change control. To discuss the changes with QA and to take approval.
- To monitor and review change control and ensure timely closer of change control.
- Co-ordination with cross functional department for production requirements and responsible for organize CFT w.r.t change control, validation & investigation.
- Preparation of Validation Protocol and reports and verify that the validation protocols and reports are reviewed and approved within the timeline.
- Involve in Qualification of new or modified facilities and equipment’s.
- Review of documents i.e. SOPs, equipment list, and cGMP documents
- To track the CAPA, take follow up for compliance and prepare the CAPA effectiveness report.
- Having knowledge to provide the appropriate CAPA to repetitive failure and for better control in manufacturing activity.
Officer
IPCA Laboratories Ltd
11.2014 - 08.2015
- Observed production work and made corrective actions to optimize performance.
- Evaluated incoming materials and finished products against standards.
- Coordinated production work between shifts by completing checklists and documenting updates.
- Organized repair and routine maintenance of production equipment.
- Determined best and most efficient uses of available resources, labor and equipment.
Jr. Officer
Glenmark Generics Ltd, Ankleshwar
05.2011 - 11.2014
- Developed new ways of manufacturing and improved existing manufacturing processes.
- Oversaw inventory and product stock to develop and maintain inventory controls resulting in cost savings and reduced overages.
- Supervised ongoing daily production phases.
- Troubleshot equipment to reduce service calls and downtime.
Trainee Engineer
PAN DRUGS Ltd
06.2010 - 04.2011
- Volunteered for additional assignments during peak work periods to keep tasks on schedule.
- Weighed and measured items to prevent waste and meet quality standards.
- Maintained organized work area by cleaning and removing hazards.
- Made sure that products were produced on time and are of good quality.
- Reviewed production schedules and streamlined processes.
Education
B. Tech - CHEMICAL
GIET/BPUT
2010
XII -
K.S.U.B
2005
B.S.C -
Pragati vidya peetha
2003
Skills
- Task Delegation
- Recruiting and Interviewing
- SAP (R/3-module)
- MS Office ( Word, Excel and Power Point)
- Track wise system
- LIMS activity
- Documentum
- Caliber QMS
- Validator
- Qedge
Languages
English
Bilingual or Proficient (C2)
Hindi
Bilingual or Proficient (C2)
Gujarati
Elementary (A2)
Timeline
Asst. Manager
J.B. Chemical & Pharmaceutical
09.2021 - Current
Sr. Executive
Raks Pharma, Amneal Pharma
06.2021 - 09.2021
GMP Asst. Manager
Zydus Cadila Healthcare Ltd
08.2015 - 06.2021
Officer
IPCA Laboratories Ltd
11.2014 - 08.2015
Jr. Officer
Glenmark Generics Ltd, Ankleshwar
05.2011 - 11.2014
Trainee Engineer
PAN DRUGS Ltd
06.2010 - 04.2011
B. Tech - CHEMICAL
GIET/BPUT
XII -
K.S.U.B
B.S.C -
Pragati vidya peetha
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