Sirisha Dandu

Lincoln RI *****.

Email: adzr9u@r.postjobfree.com

Open for Relocation

Visa Status: Permanent Resident authorized to work (Visa Sponsorship not required)

Summary:

Highly motivated and passionate pharmaceutical professional with knowledge of regulatory guidance's 21CFR, cGMP’s, regulatory submissions IND, NDA, 510(k), PMA, BLA, ICH guidelines, GxP. pre-clinical drug testing, MedDRA coding, Clinical research, Post Marketing Surveillance (PMS), Quality Management Software (QMS). Knowledge on US and EU medical device regulations, regulatory strategy development.

Experience:

Ensur DMS Administrator: Denison Pharmaceuticals, Lincoln RI 02865 (September 2022- Present)

Manage routing of various documents for approval in Quality control and Quality Assurance departments. Administration of the Ensur Document Management System (Quality Management Software).

Maintaining validation of the Ensur DMS to FDA standards.

On and off boarding users in the Ensur DMS

Generation of forms, documents, workflows, and reports from the Ensur DMS

Generation of business requirements and change control for software updates and maintenance.

Interfacing with software vendors for software updates and customization.

Prepare Standard Operating Procedures (SOP’s), Manufacturing Protocols and GMP documentation.

QA Documents Reviewer: Denison Pharmaceuticals, Lincoln RI 02865 (September 2022- Present)

Perform batch record review, Packaging work orders, Master Batch Record and BRDC’s with various departments to resolve and correct errors and ensure Good Documentation Practices are followed.

Administer the electronic document, quality, and training management systems.

Consumer Complaints: Denison Pharmaceuticals, Lincoln RI 02865 (May 2023- Present)

Work directly on technical investigations relating to Product Quality Complaints

Provide verbal and written responses/resolutions to customers regarding product quality Complaints or product inquiries.

Log all the complaints in electronic Quality Management System (ENSUR).

Career Break: 2016 September- 2022 September

Document management specialist: Denison Pharmaceuticals, Lincoln RI 02865 (September 2015- September 2016)

Creation and approval of analytical documents, stability studies SOP’s, Quality Control SOP’s etc.

Worked with Quality Assurance Department on approval of various quality control documents.

ENSUR Document Management System.

Quality support intern: Hetero Labs (2009 June -2009 December)

Worked as an intern for six months in quality control, quality assurance departments in Hetero Labs Pvt. Ltd. Hyderabad, India.

Skills acquired during internship:

Analytical equipment handling (GC, HPLC)

Acquired knowledge on product formulation and storage procedures.

Good documentation procedures and preparation of SOP’s.

Skills:

Experience in working with cross functional teams.

Knowledge on EU and US medical device regulations.

Planning and implementation of regulatory strategies.

Working knowledge of medical devices such as dental prosthetics.

RAPS member since 2014

Excellent knowledge of medical and scientific terminology.

Excellent knowledge of medical device/drugs/biologics reporting regulations and timelines.

cGMP guidelines (21 CFR part 210 and 211).

Preparation and standardization of SOPs for pharmaceutical lab procedures.

Knowledge of IND, NDA/BLA in CTD format, IDE, 510(k) and PMA, Global Regulatory Submissions, FDA and ICH Guidelines.

Proficient in Microsoft office (Excel, word and outlook).

Excellent writing and oral communication skills.

Great attention to detail.

Good interpersonal skills.

Punctual and hard working.

Academic Qualifications:

Master’s degree, Regulatory Affairs for Drugs, Biologics, and Medical Devices.

Northeastern University, Boston, MA (2013-2015)

Courses completed:

Introduction to Drug and Medical Device Regulation (RGA 6100)

Human Experimentation: Methodological Issues Fundamental to Clinical Trials (BTC 6210)

New Drug Development: A QA Regulatory Overview (RGA 6201)

Medical Device Development: A QA Regulatory Overview (RGA 6202)

Biologics Development: A Medical Overview (RGA 6200)

Food, Drug, and Medical Device Law: Topics and Cases (RGA 6203)

Master’s degree in pharmacy (Pharmacology) (2010-2012):

Experience in administering drugs to animal models.

Extensive knowledge on animal anatomy (Rats, Mice and Rabbits).

Evaluated the pharmacological activity of different drugs in animal models. (Pre-clinical drug testing).

Bachelor’s degree in pharmacy (2006-2010)

Academic Projects:

(a)Mock 510(k) submission:

Simulated a 510(k) submission for imaginary medical device: Dental prosthetic. Submission includes predicate devices, substantial equivalence, biocompatibility, performance testing, labelling and packaging. The submission also includes relevant forms such as cover sheet memorandum, truthful and accuracy statement form etc.

(b)Mock IND submission:

Pre-IND meeting request submission

IND information amendment.

IND annual reports.

Certifications:

Certificate course in pharmacovigilance ICSR case processing

Skills Acquired: Pharmacovigilance, Drug safety, ICSR, Case processing, MedDRA, Narrative writing, Causality, Labeling, Adverse Event.

Certificate course in signal detection and management in pharmacovigilance

Skills Acquired: Signal management, Signal detection, Signal validation, Signal assessment, Qualitative and Quantitative signal detection.

NIH web-based training course:

Protecting human research participants. (Certificate number: 1267959).

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