Samiksha Bhaware
Quality Management System Specialist
Hyderabad
Summary
Resourceful Manager with stellar work history, motivational approach and upbeat nature. Skilled at training employees, strategic planning, problem-solving and adapting to dynamic environments to enhance team productivity and service quality. Known for reliability, effective communication, and delivering high-quality outcomes. Highly committed with hardworking mentality to maintain quality of services and products.
Overview
11
11
years of professional experience
4
4
Languages
Work History
Asst. Manager
Biological-e-Ltd.
10.2022 - Current
- Authorized Designee to Sr. Manager.
- Implement and maintain QMS in line with respective regulatory guidelines, such as USP, EU, and ICH.
- Handling lab deviations, change control management, CAPA, LIR, Quality Risk assessment, etc.
- Execution of the equipment qualification and CSV lifecycle (URS, IQ, OQ, PQ documentation).
- Ensure cGLP, GDP, GxP, 21 CFR Part 11, and Annex 11.
- Manage documentation (SOPs, STPs, specifications, protocols, guidelines).
- Support audits and regulatory inspections.
- Maintain data integrity and training compliance.
- Supervised day-to-day operations to meet performance, quality and service expectations.
- Coordinated with vendors to ensure timely delivery of products and resolve any supply chain issues.
- Facilitated clear communication between employees and upper management through regular meetings and updates.
Scientist
Vimta Labs Ltd.
12.2018 - 09.2022
- Coordinate internal resources to ensure successful project completion.
- Implementing environmental and data integrity practices in compliance with 21 CFR Part 11.
- Responsible for handling internal and external audits, including FDA, WHO, and customer audits.
- Cleanroom validations.
- Initiation, documentation, review, and maintenance of QMS events and documentation.
- Risk assessment and impact evaluations through different mitigation tools.
- Preparations, review, and revision of SOPs, MDR, MVer, MVP/R, and batch analysis report.
- Handling LIMS (Labware 7.0) software for sample receipt, update, report release, and for unspent sample archival.
- Coordinating and conducting training plans and trainings.
- Communication with stakeholders.
Research Associate
Nagarjuna Fertilizers & Chemicals
06.2015 - 12.2018
- Critical Parameter determination, testing and troubleshooting of conversation process for rare sugar production in Continuous using immobilized enzymes.
- BCIL trainee (December, 2014 - June, 2014)
- Production of Diacylglycerides (DAG) using recombinant.
Education
M.tech - Bioprocess technology
ICT (formerly UDCT)
Mumbai, Maharashtra01-2014
B.E - Biotechnology
KITCOEK
Kolhapur, Maharashtra01-2011
Skills
Qualitative writing skills
Dynamic leadership skills
Strong analytical assessment
Ability to communicate with efficacy
Attention to detail
Time management
Problem-solving
Task delegation
Cost reduction
AUDIT KNOWLEDGE
- Key involvement as an auditee for below audits
- USFDA (Twice-2019 & 2022)
- Customer audits-MERCK, ABON, DRL, BE, etc.
Additional Information
- Quality Management/Audit System
- Risk Assessment & Impact Evaluation
- Change Management
- Handling of OOX, Deviations and Incidents.
- Computer System Validations
- Equipment Qualifications & Calibrations
- Bioanalytical Method development, verification, validation & Sample Analysis.
- Enzymatic Assay development
Accomplishments
- Foundation of project management” from Coursera by Google.
- Completed 35 hrs. PMP training through Simplilearn.
- MS Excel Advance.
INSTRUMENT COMPETANCE
- HPLC (EMPOWER)
- UPLC (EMPOWER & OPEN LAB)
- GC (EMPOWER)
- MPR (SOFTMAX PRO 7.0 & 7.0.3)
- KF Titrator (Tiamo)
Timeline
Asst. Manager
Biological-e-Ltd.
10.2022 - Current
Scientist
Vimta Labs Ltd.
12.2018 - 09.2022
Research Associate
Nagarjuna Fertilizers & Chemicals
06.2015 - 12.2018
B.E - Biotechnology
KITCOEK
M.tech - Bioprocess technology
ICT (formerly UDCT)