Quality Assurance Document Control

K. AKSHITHA

Jr. Executive - QA

*************@*****.***

91-939******* https://www.linkedin.com/in/akshitha- kesavulu-36aa87227

Hyderabad, Telangana, India.

SUMMARY

Quality Assurance Professional with experience in implementing and maintaining a Developmental Quality Assurance, Quality Mnagement Systems and delivering effective training programs to ensure compliance with regulatory requirements and company policies. Skilled in document control and quality system management, with strong understanding of GMP regulations and industry standards. Utilized expertise to drive continuous improvement and ensure high-quality products, while fostering a culture of quality and compliance within the QA department.

PROFESSIONAL EXPERIENCE

• BIOMIICRON PHARMA PVT LTD, Chennai, India

PRODUCT MANAGER - May 2023 to Nov 2023

1. Experience in launching new products or indications 2. Strong understanding of product development and commercialization processes. 3. Ability to develop and execute product strategies to drive growth. 4. Experience in managing product life cycle (e. g. launch, growth, maturity and decline). 5. Knowledge of product portfolio management principles. 6. Experience in conducting market research and gathering customer insights. 7. Ability to develop and maintain product positioning and messaging. 8. Ability to work in fast-paced environment with multiple priorities. 9. Experience in coaching and mentoring junior team members.

• GENESYS BIOLOGICS PVT LTD, Hyderabad, India

JR. EXECUTIVE(QA) - Dec 2023 & Present

1. Review and approval: Experience in reviewing and approaching study protocols, reports, SOPs, and data for compliance with regulatory requirements and company standards. 2. GMP Regulations: Knowledge of current Good Manufacturing Practices (cGMP) and guidelines including FDA, EMA, and ICH.

3. Quality Systems: Experience with quality systems such as QMS, CAPA, Deviation, Change Control and Document Control.

4. Document Control: Experience with controlling and maintaining accurate and up-to-data documentation including Standard Operating Procedures, Log books, Laboratory Note Books, Batch Processing Records and Certificate of Analysis. 5. Compliance Management: Experience with ensuring compliance with regulatory requirements, including FDA, EMA, and ICH.

ACADEMIA

• MASTERS OF TECHNOLOGY IN BIOTECHNOLOGY (Intg)

SASTRA University (2017-2022)

• Identified ligands for Osteoarthritis through virtual screening using PyRx.

• Molecular docking and Molecular dynamic simulation of Streptomyces metabolomes with beta-lactamase genes using Schrödinger Maestro tool. INDUSTRIAL VISITS

• Bozeman: Learned about Bioreactors, Fermentors, and both Upstream and Downstream processes

• Bhat Bio-Tech: Got familiar with manufacturing of Biotechnology based products.

• Aavin: Manufacturing milk products.

CERTIFIED COURSES

• Microsoft office.

• Python for everyone

• Genomics for law

• Tableau desktop professional

• Programming foundations with Javascript, HTML, and CSS.

• Data Science - Artificial Intelligence, SQL, Power BI, basics of Python, and Machine learning.

• Clinical Research – Pharmacovigilance, Regulatory Affairs, Medical Writing LANGUAGES

• English Fluent

• Kannada Fluent

• Telugu Fluent

• Tamil Intermediate

PROJECTS

6. Trainings: Coordinated and maintained accurate records of activities in training program for cross-functional departments, ensuring compliance with regulatory requirements and company policies.

7. Time Management: Ability to manage time effectively and meet deadlines. 8. Adaptability: Willingness to adapt to changing requirements and priorities. 9. Collaboration: Ability to work collaboratively with cross-functional teams, including manufacturing, regulatory affairs and Quality Control and building strong relationships. 10. Communication: Excellent communication and interpersonal skills. 11. Strong knowledge on Microsoft office, including Word, Excel, PowerPoint, and Outlook.

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