Mahendra Berad
Senior QC Professional | 13+ Years Pharma Experience (Injectables, Liquids, OSD)
Indore
Summary
Currently working as a Sr. Analyst at Endo par formulation Pvt Ltd. Leading projects for injectable and oral dosage forms. Possess a diverse skill set including Method Validation, method transfer, Method Verification, Stability Testing, In-process and Finished Product section. Proficient in preparing and Analysis of Method Transfer/Verification/Feasibility/ Validation protocols and Reports. Capable of managing complex projects for injectable and oral dosage forms. Extensive knowledge in analytical method Transfer. Expertise in regulatory requirements and compliance, ensuring adherence to industry standards. Skilled in managing activity for Analytical Method Verification, Transfer, Stability studies, In-Process and Finished Product section. Instrument Audit Trial review and 21 CFR part 11 Compliance. Working with Complies SOP, regulatory requirement like cGMP, ALCOA, ALCOA+, Safety and regulatory
Overview
13
13
years of professional experience
Work History
Sr. Analyst - Analytical Method Verification and Transfer
Endo India Par Formulation
05.2021 - Current
- Leading method transfer activities, such as preparation of protocol, execution, report, approval activity, and analysis.
- Leading lab compliance and human error reduction projects.
- Implementation of cost-saving activity projects during procurements.
- Conduct an internal audit to find gaps in procedures and practices within the Quality department.
- Effectively working in Analytical Method Transfer.
- Review and preparation of the analytical method verification and transfer protocol, and report.
- During laboratory activity, follow the ALCOA, ALCOA+, and ALCOA++ principles.
- Ensure GLP, GDP, and GCP during day-to-day activities in the laboratory.
- Sample management and disposal activity.
- Monitoring and review of the analytical testing activities.
- Imparted training for analysts on SOPs before the initiation of a new activity.
- Implementation of the ISO 14001:2015 Standard for Environmental Management Systems as an internal auditor.
Officer: Stability
Emcure Pharmaceutical Ltd
11.2016 - 05.2021
- Analysis of commercial and exhibit stability injectable batch samples.
- Performing related substances, degradation products, assay, and preservative content analysis processing and reporting.
- Performing the Osmolarity Analysis using an osmometer.
- Solve the issue related to chromatographic activity, i.e., HPLC. UPLC, etc.
- Implementation of the 5S activity to minimize laboratory errors.
- LIMS Activity.
- Data complies.
Officer - In-process and Finished Product
Centaur Pharmaceutical Pvt Ltd
06.2015 - 11.2016
- Analysis of in-process and finished product for the sample.
- Performing related substances, content uniformity, preservative content, and assay analysis, processing, and reporting.
- Solve the issue related to chromatographic activity, i.e. HPLC.
- Implementation of the 5S activity to minimize laboratory errors.
- LIMS activity (LIMS).
- Data complies.
- Established effective relationships with key stakeholders both internally and externally for increased collaboration opportunities.
Assistant Chemist
Omni Protech Drugs Pvt Ltd
09.2012 - 12.2014
- Testing of in-process and finished product of liquid and OSD samples.
- Performing related substances, content uniformity, preservative content, and assay analysis by HPLC processing and reporting.
- Performing raw material analysis.
- Maintaining the documents and laboratory logbooks.
Education
Bachelor of Pharmacy -
Savitribai Phule Pune University
Pune07.2012
Skills
- ANALYTICAL METHOD TRANSFER
- ANALYTICAL METHOD VERIFICATION
- STABILITY
- IN-PROCESS
- FINISHED PRODUCT
- HUMAN ERROR REDUCTION
- COMPLIANCE MANAGEMENT
- HPLC (WATERS, SHIMADZU, AGILENT)
- UPLC (WATERS)
- FTIR
- UV (SHIMADZU, PERKIN ELMER)
- DENSITY METER- ANTON PAAR
- RELATED SUBSTANCES
- ASSAY
Accomplishments
- Recognized with the “Above and Beyond” Award for outstanding contribution to Quality Control operations.
- Honored as “Analyst of the Month” for superior analytical performance and regulatory adherence.
Personal Information
- Notice Period: 2 months
- Date of Birth: 19th Oct 1990
- Marital Status: Married
Timeline
Sr. Analyst - Analytical Method Verification and Transfer
Endo India Par Formulation
05.2021 - Current
Officer: Stability
Emcure Pharmaceutical Ltd
11.2016 - 05.2021
Officer - In-process and Finished Product
Centaur Pharmaceutical Pvt Ltd
06.2015 - 11.2016
Assistant Chemist
Omni Protech Drugs Pvt Ltd
09.2012 - 12.2014
Bachelor of Pharmacy -
Savitribai Phule Pune University