Krisha DESAI
Summary
To obtain a challenging career to utilize and update the technical/ managerial skill thus grow along with organization.
Overview
4
4
years of professional experience
Work History
QA Executive
Dial pharmaceuticals
08.2023 - Current
- Ensure products manufactured by the co-manufacturer are checked and tested according to the Quality Plan, and that records are well maintained.
- Managing day-to-day proactive draught quality calls, dispense, and emergency callout operations within the priority framework.
- Ensure the company’s QMS processes, such as batch release, product complaint, incident management, change control, deviation, CAPA, and risk management, are effectively implemented.
- Carry out internal and external audits (self-inspection).
- Responsible for the final inspection stage (PDI) and checking all the finished goods products.
- Preparation and Review of BMR and BPR.
- Preparation of the Standard Operating Procedure (SOP) as per the Company Profile.
- Preparation and review of process validation, media fill validation protocol, and report.
- Assisting with the preparation, execution, and follow-up of external inspections.
- Support the implementation and maintenance of effective Quality Assurance systems to ensure that local operations are in full compliance with Dial's standards and policies.
- Preparation of the Validation Master Plan and the Site Master File.
- Preparation of additional license documents as per drug requirements.
- Created SOPs for QA processes and ensured their implementation across all departments.
- Developed and implemented quality assurance policies, procedures, and processes to ensure product compliance with established standards.
- Conducted routine inspections of production facilities to identify areas for improvement.
- Evaluated customer complaints and conducted investigations into non-conforming products.
- Provided guidance on best practices related to quality control activities throughout the organization.
- Coordinated with internal departments to ensure timely resolution of quality issues.
QA & QC Officer
Sanolet Life care Pvt. Ltd.
01.2021 - 08.2023
- Audit support activity.
- EU Gap Analysis Process.
- Document and data control activities.
- BMR and BPR prepare and review.
- Preparation of Master Formula Record (MFR).
- SOP preparation as per WHO TRS & EudraLex volume 4 guideline
- Protocol preparation, such as stability protocol, process validation protocol, and report.
- Media Fill Validation (7.5 ml, 10.0 ml, 20.0 ml, and 30.0 ml)
- Issuance and retrieval activity of Formats and Logbook.
- BMR and BPR from Pharmacloud.
- Log book of all instruments and equipment's, all registers.
- Self-inspection for cross-functional departments.
- Design (artwork) verification and approval of products.
- Organize regulatory documents to supply the customer.
- Handle regulatory-related documents (review STP, MOA, stability report, and CoA).
- Application and preparation of the Product Permission (PP), Combi Pack Product Permission, Certificate of Pharmaceuticals Products (COPP), and FSC Export and Domestic.
- Co-ordination with concern customer for RA activities
- Conducted regular audits and inspections of production lines to ensure compliance with quality standards.
Education
M.Sc. - Biochemistry
Nirma University
Ahmadabad01.2021
B.Sc. - Bachelor of Science
Saurashtra University
Amreli01.2019
H.S.C -
Gujarat Higher Secondary Education Board
01.2016
S.S.C -
Gujarat Higher Secondary Education Board
01.2014
Skills
- MS Word
- MS Power Point
- MS Excel
- ERP PHARMACLOUD
- ERP PHARMASUITE
- Investor Facilitation Portal (IFP)-Application and Downloading online certificates, Licenses ,Downloading online Product Permission (PP), Certificate of Pharmaceuticals Products (COPP)
- SHUGAM PORTAL (CDSCO)
Audits faced
WHO-GMP, Botswana, Tanzania, Iraq, Nepal, Yemen, Hester Biosciences, Lincoln pharmaceuticals, Cipla, Halewood Pharma, Opes Healthcare Pvt. Ltd., Emcure Pharmaceuticals, Cadila Pharmaceuticals
Languages
- English, professional working proficiency
- Hindi, full professional proficiency
- Gujarati, native or bilingual proficiency
Areas Of Interest
WHO & EU Certification Support activities.
Strengths
- Hard working
- Team Leader
- Learner
- New task Compliance
Personal Information
- Father's Name: Mansukhbhai Maganbhai Desai
- Date of Birth: 25/003/1999
- Marital Status: Single
Timeline
QA Executive
Dial pharmaceuticals
08.2023 - Current
QA & QC Officer
Sanolet Life care Pvt. Ltd.
01.2021 - 08.2023
M.Sc. - Biochemistry
Nirma University
B.Sc. - Bachelor of Science
Saurashtra University
H.S.C -
Gujarat Higher Secondary Education Board
S.S.C -
Gujarat Higher Secondary Education Board