C Sai Sathavahana

QUALITY ASSURANCE

Profile
Personal Details
Highly motivated and detail-oriented professional with 10+ years of experience and
Hyderabad,
a strong background in quality management and compliance within the pharma-
9542917642/ 9014617642
ceutical industry. Experienced in leading Market Complaints, Product Recalls, inci-
sai.pharma42@gmail.com
dent investigations, implementing CAPAs, OOS, Trainings, Document reviews, Audits,
Qualifications and ensuring regulatory compliance. Proven track record of driving N AT I O N A L I T Y

process improvements and automation. Effective in reviewing and responding to Indian

Health Authorities and external party observations. Strong expertise in preparing and PLACE OF BIRTH
reviewing SOPs and providing GMP/ Data Integrity/ Good Documentation Practices Tirupathi
(GDP) training to personnel.

Skills
Education Communication Skills

M.Pharm in Pharmaceutics, JSS College of Pharrmacy, Mysore Ability to Work Under Pressure
04/2010 - 05/2012
Adaptability

B.Pharm, Sree Vidyanikethan College of Pharmacy, Tirupathi Fast Learner

04/2006 - 03/2010
Ability to work in a team

Ability to Multitask

Team leadership
Employment History
Critical thinking and problem solving
Deputy Manager - QMS, Hetero Biopharma Limited, Hyderabad
Incident Management
05/2021 - Present

- Leads Change Control/ Change Requests, Market Complaints, Product Recalls, inci- CAPA Management
dent/ Deviation management, OOS investigations and implementation of Corrective
Audit
Action and Preventive action (CAPAs) for the identified discrepancies followed by
timely closure.
Training
- Selection, Review, Scheduling & Auditing of Vendor & Suppliers followed by estab-
Document Management
lishing Quality and Supplier Agreements and timely updation of Vendors/Suppliers list.

- Handle Internal (Self-inspection) and External Audits (Health Authorities & Cus- Vendor Management
tomers) and timely closure of agreed CAPAs.
Market Complaint
- Ensuring implementation of LMS, including course creations, assessments & monitor
training completion followed by audit trails. Risk Management

- Impart cGMP/ Data integrity/ Good Documentation Practices/ Change Manage-

ment/ Incident Handling & its tools, etc., as part of continuous improvement to QA

Projects Handled
and Cross functional Teams.

- Review and approve of Annual Product Quality Review (APQR) & QRM.

- Prepare, review, and approve Standard Operating Procedures (SOPs).

• Implementation of LMS
- Prepare and track Quality Metrics for continuous process improvement. & FIORI at Dr.Reddy's
Laboratories Ltd (FTO 1)
- Ensure implementation and compliance with emerging/ new regulations within
defined time frames.
Trainee - Asst. Manager, Dr. Reddy's Laboratories Ltd. , Languages
Hyderabad/ Vizag
Telugu
10/2012 - 01/2021

- Supporting Regulatory affairs in filing dossiers and fulfilling the deficiencies/ queries English
received from the agency (US, MHRA, EU, Health Canada, Ukraine, Argentina, Japan,
Russia, TGA, Mexico, China & Brazil). Hindi

- Handle Change Controls/ Change Management, Incidents, CAPAs and Internal & Tamil
External Audits.

- Handle Complaint management, Product recalls & Product returned goods.

- Configured the LMS with access levels within the LMS, uploading of the content,
including courses, modules, assessments, and other learning materials, into the LMS.
Strengths
Providing technical support to LMS users, including employees, trainers, and other
- Strong presentation and com-
stakeholders, to resolve any issues or challenges related to the system's functionality.
munication skills.
- Conduct training sessions for LMS users, including new employees and trainers, to
- Creative and detail-oriented.
familiarize them with the platform's features and functionalities.
- Time management, multitask-
- Monitor and track compliance training completion to ensure that all employees meet
ing, proactive, and self-motivat-
mandatory training requirements.
ed.
- Vendor Management for the LMS system, including contract negotiations, Service
- Ability to monitor, train and
level Agreements (SLAs) & regular feedback.
coach individuals.
- Perform in-process checks for various solid dosage forms during manufacturing and
- Problem-solving, organization-
packing stages.
al, and leadership skills.
- Document Reviews such as Batch Manufacturing Records (BMRs) and Batch Packing
- Ability to work independently
Records (BPRs).
and in a team.
- Collect and manage in-process, finished product, validation, Control and stability
- Warm, friendly, and engaging
samples.
personality.
- Review and Approval of Artworks.
- Calm and composed under tight
- Prepare site Quality metrics and arrange Monthly QRM Meetings for Management deadlines.
review.

- Prepare Site Master File and Quality Manual.

- Prepare, Review & Approve Standard Operating Procedures (SOPs). Hobbies

- Prepare & Review of Annual Product Quality Review (APQR). - Watching Movies

- Driving

Softwares handled
- Travelling

- Photography

- Music
• SAP, ERP & FIORI systems for Quality Management System (QMS)

• DocHub & DMS for Document Management System (DMS)

• LMS & Caliber for Learning Management System (LMS)

• MES (Manufacturing Execution System) for electronic batch records (e-BMRs)

• Well versed and experienced in Microsoft Applications such as Word, Excel, ppt

Regulatory Audits faced

- USFDA, ANVISA, Health Canada, WHO, Ukraine, Russia, Kazakhstan, Belarus, Mex-
ico & Colombia.