Sadiya Sultana
Hyderabad
Summary
Dynamic quality assurance professional with extensive experience at Dr. Reddy's, adept in regulatory compliance and change control. Proven track record in reducing query resolution time by 20% through meticulous documentation audits. Strong communicator and critical thinker, skilled in validation protocols and quality management, ensuring adherence to industry standards.
Highly-motivated employee with desire to take on new challenges. Strong work ethic, adaptability, and exceptional interpersonal skills. Adept at working effectively unsupervised and quickly mastering new skills.
Overview
10
10
years of professional experience
Work History
Manufacturing quality assurance
Dr.Reddys
Hyderabad
06.2016 - 06.2022
- Handling of change control, deviation, incident, out of specification, complaints and return goods.
- Prepration and review of validation protocols and validation reports.
- Handling of Internal audits and Training as per Schedule.
- Reviewing of completed Batch Production Record & Analytical raw data
- Filling vendor questionnaires and checking vendor qualification.
- Coordination with External audits and audit compliance.
- Prepration and review of SOP's.
- Reviewing of BPCR & STP as per technology transfer documents for batch execution.
- Review of Method development/validation/verification/ transfer.
- Prepration and review of Annual Product Quality review (APQR).
- Participated in commercial dispatch activities and QA release.
- Involving in line clearance activities.
- Responsible for issue, retrieval, archival and distribution of documents, on line documentation and focus on data integrity.
Regulatory Affairs executive
MSN Laboratories Pvt.Ltd
Hyderabad
03.2014 - 03.2016
- DCGI Liaison: Preparing and Submitting applications and handling queries from the CDSCO.
- Form Preparation: Filling out essential forms ( e.g., Form 44 for clinical trails/ new drugs, Form 10/11 for import).
- compliance: Ensuring all promotional materials, labelling, and product information comply with CDSCO requirements.
- Successfully prepared and submitted comprehensive dossiers for new drug approvals and import licenses to the DCGI(CDSCO).
- Reduced query resolution time by 20% by meticulously auditing documentation against Drugs and Cosmetics Act requirements prior to filling Form 44.
- Maintained lifecycle documentation for renewals, and labelling updates in strict compliance with ICH guidelines.
- Managed regulatory inspections and prepared responses to queries regarding BE (Bio equivalence) study approvals.
- Successfully obtained Import Licenses ( Form 10) and No objection Certificates (NOC) for clinical trial samples.
- Regulatory Frameworks: CDSCO, DCGI guidelines, Drugs & Cosmetics Act.
- Key Action Areas: Query Response and Regulatory Compliance.
Research and Development - Quality Assurance
Biocon pvt Ltd
Bangalore
10.2012 - 02.2014
- Preparation & Review Development Reports and Tech transfer development reports.
- Preparing, reviewing & approving templates of formatted documents.
- Preparation of QMS, WHO & USFDA Audits documents.
Education
B pharmacy, Nizam Institute of Pharmacy
Hyderabad Intermediate, Vikas Junior College
Hyderabad Skills
- Change control
- Validation protocols
- Regulatory compliance
- Quality management
- Communication: Verbal, written and active listening
- Problem - solving & critical Thinking: analyzing situations to solve complex issues
- Time Management & Organization: Prioritizing tasks efficiently
- Software skills: Microsoft office ( Excel, Word & Powerpoint)
Languages
English
Proficient (C2)
C2
Hindi
Proficient (C2)
C2
Telugu
Upper Intermediate (B2)
B2
Timeline
Manufacturing quality assurance
Dr.Reddys
06.2016 - 06.2022
Regulatory Affairs executive
MSN Laboratories Pvt.Ltd
03.2014 - 03.2016
Research and Development - Quality Assurance
Biocon pvt Ltd
10.2012 - 02.2014
B pharmacy, Nizam Institute of Pharmacy
Intermediate, Vikas Junior College