Radhe Shyam
Pharmaceutical Professional
Dehradun
Summary
A Quality & Compliance professional skilled with commendable experience (more than 17 Years) in plant Quality functions of Pharmaceutical formulation dosage forms.
Possess multifarious experience in Quality Assurance, Compliance, Auditing (Vendor development, Packaging material manufacturing facility), Quality Control Laboratory, Laboratory compliance, Documentation, Project Management and Lean Management.
Competencies in deriving substantial improvements across diverse business processes with implementation of latest Quality Management Tools.
Overview
18
18
years of professional experience
3
3
Languages
Work History
Quality & Compliance
GETWELL Pharma India Pvt. Ltd
08.2023 - Current
- Responsibility of overseeing plant activities including for Quality Operations to meet business objectives in consideration of all the dimensions i.e., people related, Quality, financial, customer and CFT team (Engineering and maintenance, warehouse, Quality control/assurance, Human resources and Production).
Quality Assurance/Quality Control Manager
MANKIND PHARMA LTD.
05.2019 - 06.2023
- Managing day to day activities of Quality Assurance and Quality Control.
- QMS management (Change Controls, Deviations, CAPA, OOS etc.).
- Responsible for IPQA activities.
- Budget (CAPEX & OPEX) preparation for smooth operation.
- Documentation and control.
- Lab commissioning and decommissioning.
Quality Assurance Manager
AUROBINDO PHARMA LTD.
05.2016 - 05.2019
- Laboratory Quality Assurance, Quality Control Compliance function (Injections-Dry powder & Lyophilized)
- Implementation of Quality Management System, Corporate Quality Policy, Training Policy and Procedures.
- Handling of data Integrity issues.
- Stability Management
- Release the raw materials and finished products.
- Participating in the investigations of market complaints.
- Evaluatation and approval of the Quality systems viz.-OOS, Deviations (PNC’s), Investigation
Quality Assurance & Compliance Manager
IPCA Laboratories Ltd
05.2015 - 05.2016
- Responsible for IPQA activities at shop floor.
- Responsible for Management of Quality Assurance, CGMP/GLP, functions and harmonization of procedure.
- Handling Deviations, Impact assessment, GAP analysis, CAPA, OOS, OOT and Investigations.
- Evaluation and approval of change controls with impact assessment.
- To perform the batch release to the market.
- Handling & investigation of market complaints.
Quality Assurance
RANBAXY LABORATORIES LTD
05.2012 - 05.2015
- Review the analytical data OSD formulations, Innovator samples, Process Validation, Multimedia & Single media related data.
- Maintaining the Documents and record of IPQA samples.
- Implementation of cGMP & GLP practice in Lab.
- To perform OOS, Deviations & incidents Investigation.
Quality Control
INTAS PHARMACEUTICALS
12.2009 - 02.2012
- Analysis and review of the finish product dosage forms like; Tablets, capsules.
- Handling of SAP for data punching.
- Preparation of water trends.
- Maintaining the GLP in the laboratory.
- Calibration of instruments likes HPLC, Dissolution, Balance etc.
Quality Control
PIRAMAL HEALTHCARELTD
09.2007 - 12.2009
- Analysis and reporting of Injections, OSD and Ophthalmic dosage forms using HPLC and GC.
- Water trends preparation.
- Environmental monitoring
- Reviewing the raw data and release in SAP as per requirement.
- STP, GTP, SOP, Specification, raw data sheets, COA preparation.
Quality Control Supervisor
Zydus Cadila Group
02.2006 - 09.2007
- Worked in greenfield project at Zydus Sikkim.
- Analysis of finish products, raw materials and in-process samples w.r.t chemical and Microbiology.
- Media Preparation (Plate preparation, MLT).
- Water sampling and testing.
- Environmental Monitoring.
- Preparation of documents like SOPs and STPs.
Education
Master of Science - Chemistry
M P Bhoj University
Bhopal, Madhya Pradesh 04.2001 -
Master of Science - Microbiology
H.N.B Garhwal University
Srinagar, Uttarakhand 04.2001 -
Bachelor of Science - Chemistry
H.N.B Garhwal University
Srinagar, Uttarakhand 04.2001 -
Skills
Internal Auditing
Experience Purview
Finished Dosage Forms like Tablets, Hard and Soft Gelatin Capsules, Liquid Orals, Injectable & Ophthalmic.
Regulatory: USFDA, EU-GMP, MHRA, ANVISA, MCC, WHO-GMP.
Customer: Customer Audits, majorly by Mylan, Teva, Ajanta Pharma, Apotex, Novartis, Actavis, Bristol etc.
Accomplishments
- Handing of Audits (regulatory as well as internal)
- USFDA- 4 time
- ANVISA- 2 time
- EU GMP- 2 time
- WHO-3 time
- Multi-agency- 1 time
- Consultant-2 time
- Customer-Multiple time
Timeline
Quality & Compliance
GETWELL Pharma India Pvt. Ltd
08.2023 - Current
Quality Assurance/Quality Control Manager
MANKIND PHARMA LTD.
05.2019 - 06.2023
Quality Assurance Manager
AUROBINDO PHARMA LTD.
05.2016 - 05.2019
Quality Assurance & Compliance Manager
IPCA Laboratories Ltd
05.2015 - 05.2016
Quality Assurance
RANBAXY LABORATORIES LTD
05.2012 - 05.2015
Quality Control
INTAS PHARMACEUTICALS
12.2009 - 02.2012
Quality Control
PIRAMAL HEALTHCARELTD
09.2007 - 12.2009
Quality Control Supervisor
Zydus Cadila Group
02.2006 - 09.2007
Master of Science - Chemistry
M P Bhoj University
04.2001 -
Master of Science - Microbiology
H.N.B Garhwal University
04.2001 -
Bachelor of Science - Chemistry
H.N.B Garhwal University
04.2001 -
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