RAVI BHATT
London/Hounslow,UK
Summary
I want to become a highly skilled professional and to add value to the organization I work for, by having a focus on continuous learning while retaining my problem-solving attitude. Quality & Regulatory Affairs and Quality Assurance with about 5 years of experience in pharmaceutical manufacturing. In-depth knowledge of cGMP, regulatory, Pharmaceutical industry, ICH, EMEA and corporate guidelines and requirements. Proven leadership skills with the ability to provide guidance and mentor ship to junior staff to achieve business objectives and manufacturing goals. Determined Quality Assurance Specialist with dedication to quality and accuracy. Familiar with handling multiple projects in highly competitive environments. Solid interpersonal and collaboration skills.
Overview
8
8
years of professional experience
Work History
Care Assistant
Franklin Care Home
10.2023 - Current
- I help people live as comfortable much as possible
- Assist them with personal, personal care, preparing and serving food, administering and topical medication as per prescription under supervision, cleaning flat and providing emotional support during their call times
- I do excellent communication with them also.
Quality Regulatory Affairs Executive
Baroque Therapeutics Pvt Ltd
Anand
01.2017 - Current
- Working with Research and Development firm for formulation of Solid and Liquid Orals
- Application of Product license, Certificate of Pharmaceutical Product, Free sale certificate, Not of standard quality as per FDA rules & regulations
- To Prepare, Review & Compilation of CTD, ACTD & Non CTD Dossiers for below Listed countries in ROW Market
- ASEAN Countries (Vietnam, Cambodia, Myanmar, Philippines, Thailand, LAO PDR)
- African Countries (Cameroon, Nigeria, Madagascar, Kenya, Malawi, Sierra Leone, Uganda, Peru, Dominican Republic)
- Latin American Countries (Chile, Curacao, Paraguay, Honduras, Guatemala, Nicaragua, Suriname)
- Afghanistan
- Involved in Regulatory compliance and timely submitting the document for regulatory submission (Related to new product launch and regulatory query- based documents)
- Expert in EMEA, ICH , cGMP, CTD, ACTD and ISO guidelines
- Safe operations of variation filing application along with its supplementation
- Technical Evaluation of Product development report and Master formula record
- Monitoring sampling of Process validation for Tablets, Capsules, Oral Liquids & Powder for oral reconstitutions dosage forms and confirming the plans and results of process validation
- Reviewed and analysed batch records, stability reports, dissolution profiles, validation protocols and reports for various dosage forms
- Support the development, communication, and implementation of global regulatory strategies in support of team goals and product portfolio execution
- Review of artworks, Package inserts and labelling information as per respective rules defined in Drug & Cosmetic Act and specific country requirement
- Prepared and supported legalization activities for various international markets for registration purpose
- Responsible for monitoring and maintaining quality and compliance targets
- Communication to other departments for any shortfall for documents as per planning.
Quality Assurance Officer
Baroque Pharmaceuticals Private Limited
01.2016 - 01.2017
- Issue and Review controlled cGMP Documents of Manufacturing area and Quality control area
- Collection samples at various stage of manufacturing as well as process validation sampling and cleaning validation sampling
- To carry out In process Quality Controls for Solid Orals and Liquid Orals
- Report Deviations, Incidents and Quality issues in Manufacturing
- Upheld and reinforced compliance with cGMP, including Good Documentation Processes and existing SOPs
- Assisted with internal and vendor audits, including pre-audit preparations
- Worked with General, Penicillin and Cephalosporin Products
- Reviewed and approved executed batch records, liaised between Manufacturing and QA during batch record reviews, and facilitated communication between QA and client
- Uncovered opportunities for process or quality improvement and submitted recommendations to production coordinators to improve batch records for future use
- Maintained QA logbooks for document change control, instrument calibration schedules, stability pull schedules, test method and technical reports, and certificates of analysis
- Provide support to GMP manufacturing activities, including GMP materials release, shipment verification, and performance of line clearances in Class 100,000 and 10,000 environments
- Coordinated with Operations personnel to identify and resolve internal quality issues
- Assisted with internal and vendor audits, including pre-audit preparations
- Ensure facility compliance with cGMP and FDA regulations, best practices, and standards of quality
- Spearhead and support investigation/CAPA activities relating to product release such as conducting and producing investigation reports, coordinating corrective and preventive action execution, managing change controls, and performing CAPA effectiveness checks
- Write, review, and approve deviations, corrective and preventive actions, change controls, specifications, standard operating procedures, test methods, stability and process protocols, and test results
- Manage equipment calibration, qualification, and maintenance program
- Manage Cleaning validation program
- Preparations of Guidelines and Standard Operating Procedures for related Operations and Functions
- Write and review Deviations, Corrective Actions, preventive Actions, Change controls and Out of Calibrations reports
- Review and Validate labelling and distribution documentation
- Manage Equipment Calibration, Qualification and Maintenance program
- Training program for juniors for Compliance guidelines and Standard Operating Procedures
- To evaluate operations performed by Subordinates.
Project Trainee
Baroque Pharmaceutical Pvt. Ltd
Khambhat
06.2015 - 12.2015
- Executed project on " RISK BASED APPOARCH FOR QUALIFICATION AND VALIDATION OF PHARMACEUTICAL PURIFIED WATER FOR BETA LACTUM PLANT"
- Considered Risk based approach in performing Purified Water Validation in Penicillin and Cephalosporin plant using WHO TRS 937 guidelines and applied Quality Risk Management using FMEA tools as per ICH Q9
- Key Points:
- Purified Water Validation
- According to WHO TRS 937 and other Guidelines, Identify critical quality attributes(CQA) and Critical process parameter (CPP)
- Applied Quality risk management each n every stage using Failure Mode Effects Analysis (FMEA) as per ICH Q9 guidelines.
Education
MBA - Hospital and Health Service Management
University of Bedfordshire | University Square Campus
11.2023
Master of Pharmacy - Quality Assurance
Anand Pharmacy College
India 04.2001 -
Bachelor of Pharmacy - Pharmacy
Sat Keval College of Pharmacy
04.2016
Skills
- Pharmaceutical Quality Manufacturing
- Current Good Manufacturing Practices (cGMP)
- Good Documentation Practices
- Quality Management Systems
- Regulatory Compliance
- Corrective and Preventive Action Planning
- Effective Communication skills
- Enthusiastic
Interests
Interest:
, Travelling
Dance
Music
Play cricket
Reading Personal Information:
Father's Name
Additional Information
- General knowledge of the pharmaceutical industry Strong verbal and written communication skills Good interpersonal skills Team Work Ability to manage priorities Proficiency in the use of common and specialized software.
Languages
English
Advanced
Hindi
Native
Gujarati
Native
Timeline
Care Assistant
Franklin Care Home
10.2023 - Current
Quality Regulatory Affairs Executive
Baroque Therapeutics Pvt Ltd
01.2017 - Current
Quality Assurance Officer
Baroque Pharmaceuticals Private Limited
01.2016 - 01.2017
Project Trainee
Baroque Pharmaceutical Pvt. Ltd
06.2015 - 12.2015
Master of Pharmacy - Quality Assurance
Anand Pharmacy College
04.2001 -
MBA - Hospital and Health Service Management
University of Bedfordshire | University Square Campus
Bachelor of Pharmacy - Pharmacy
Sat Keval College of Pharmacy
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