Uma sankar sahu
Quality Assurance
Hyderabad
Summary
To obtain a challenging and responsible position of Quality Assurance department that facilitates learning and provides strong communicational, organizational and technical skills. I feel that my leadership quality as well as the previous work experience will help me to serve better for the organization.
Having very good experience in preparing APQR's/ PQR’s (Annual Product Quality Review). ESO CMO Batch record review and batch release. QMS Activities (Incidents/ Customer Complaints/ CAPA/ Change Control). Review and circulation of Change controls and its timely closure Familiar knowledge of IPQA activity in the Production process and Batch Release process. Preparation of PPTs and meeting schedule of Management reviews (BU and Senior management)
Overview
1
1
Language
18
18
years of professional experience
Work History
Associate Manager
Novartis
09.2021 - Current
- Transition coordinator:
- Develop and implementation of detailed transition plans, including timelines, milestones, and resource allocation.
- Facilitate regular meetings, workshops, and progress reviews to ensure alignment with stakeholders effectively.
- Collaborate with stakeholders to define transition objectives, scope, deliverables and budget.
- Identify risks and develop contingency plans to mitigate potential challenges.
- Collaborate with cross functional teams to ensure successful execution of transition plans and resolve transition related issues
- Align transition strategies with the organization's overall goals and objectives.
- Maintain accurate documentation of transition plans, progress, and outcomes.
- Handling of Stakeholder negotiations.
- Quality Management System – CAPA, Market complaints & Self-inspection
- Support in achieving Internal Audits Schedule adherence and on-time closing of Action Plans, area audits and Global audit schedule, Supplier / Key Service Provider Audits with in the Quality Service Center.
- Maintains the effectiveness of the CAPA system records to ensure audit-readiness for internal and external quality system audits within the area.
- Compile, analyze and report CAPA metrics data for Daily Tracking, Weekly Deck, Fortnightly, Monthly & QRM for Tier & Governance Meeting.
- Conduct routine self-inspection and Monitoring assessment to ensure the compliance with cGMP.
- Monitoring of KQI, Preparation of QRA and Self inspection risk assessment for the team.
- Preparation of annual training plan in the team and tracking of the upcoming overdue trainings.
- Initiates role-based training program for new associates or associates in new role.
- Responsible for maintaining the training relevant documents (e.g. CVs and JD and training qualification for archiving).
- Deviation investigator for the team.
- Handling of Technical Market Complaints in AQWA-Q, Trackwise and 1QEM system.
- Review and Approve Product Quality service operations like Investigation Reports received from CMOs against Market complaints, GxP documentation and Global Audit support
- Preparation of Market Complaint Trending Report using QANTO (Qlik Sense) Software for all the ESO & NTO.
- Batch Release (FP/DP/DS):
- Review batch manufacturing records (BMR) and associated documentation like (COA, COC, BMR, etc) to ensure compliance with regulatory requirements, SOP and quality standards.
- Inspections and verifications of product labels, packaging materials component and packaging photographs, and batch numbers to ensure accuracy and adherence to specifications.
- Perform and evaluate investigations and deviations, support in OOS and review of change controls.
- Participate in continuous improvement initiatives (CI) to enhance the efficiency, quality, and compliance of the batch release process
- Collaborate with Supply Chain and ESO QA/ CMO to prioritize and schedule the release of finished goods in accordance with customer demands
- Preparation of SOPs/ WPs/ ATT and review of control procedures.
- Create overviews, reports and lists (e.g. reporting), communicate with collaboration partners/ ESO QA/ ESO CMO.
- Audit Faced: USFDA, TGA, Brazil, CHINA, Internal Global Audit and Customer Audit
Assistant Manager
Dr. Reddy’s Lab. Ltd
03.2015 - 09.2021
- IPQA - Shop floor Activities:
- Managed a team of 8 employees to successfully deliver multiple tasks on time.
- Handling of Deviations, OOS/ OOT investigations, and writing the investigations.
- Imparting cGMP and data Integrity training for employees.
- Execute GEMBA Walks on the shopfloor according to the schedule and document observations to ensure adherence.
- Review of batch manufacturing record (BMR) in MES tool and Manual batch records and stage-wise yield reconciliation during the manufacturing process and packing and its Batch Release.
- Responsible for IPQA activity during manufacturing process like line clearance, in process entries, sampling etc.
- Audit Compliance and QMS (Quality Management System)
- Review and circulation of Change controls and its timely closure
- Review Change controls to evaluate impact of the change with respect to reportability and product restriction for any product in scope.
- Preparing a audit schedules and tracking adherence of audits as per annual audit schedule
- Monitor and track the progress of Deviation closure, ensuring adherence to timelines and compliance
- Conduct regular reviews of external 483 observations received from regulatory agencies or other external entities.
- Evaluate the potential impact of each observation and prioritize them accordingly.
- Document all findings, actions taken, and outcomes from the external 483 reviews.
- Monitor and track the progress of Audit CAPAs and Deviation CAPA, ensuring adherence to timelines and compliance with regulatory requirements.
- Played a key role in the development and implementation of the company's Quality Management System in compliance with GMP regulations.
- Actively engaged in regulatory audits and customer audits, contributing to the successful completion and compliance.
- Prepared comprehensive responses to regulatory audit findings, ensuring adherence to regulatory requirements.
- Maintained compliance with audit observations by implementing necessary corrective actions and process improvements.
- Reviewing of Quality assurance agreements and Preparation and review of FDA quality metrics.
- Preparation of PPTs and meeting schedule of Management reviews (BU and Senior management) and tracking MOM action and closure.
- APQR
- Compilation & review of Annual Product quality review (APQR) Reports as per monthly schedule.
- Extraction, compilation and statistical evaluation of analytical data-Critical Quality Attributes (CQA’s) of the product using control charts in Minitab.
- Evaluation of Critical Process Parameters (CPP’s) at various stages of the manufacturing as part of Annual Product Quality Review (APQR)
- Extraction, compiling & Summarization of reported Change controls, deviations & Out of specification & Out of trends, Market complaints, Recalls etc. in APQR report.
- Market Complaint:
- Handling the complaint through electronic complaint management.
- Perform complaint investigations in a timely manner to determine the root cause and provide appropriate CAPA.
- Ensuring adequate support and requirement of documents in case of FAR & Recalls
Sr. Chemist
Mylan Lab. Ltd.
02.2012 - 02.2015
Jr. Officer
IPCA Lab. Ltd.
08.2010 - 12.2011
PSR
Ranbaxy and Nicholas Lab Ltd.
01.2008 - 01.2010
Education
Bachelor’s - pharmacy
Biju Patnaik University
OrissaSkills
Batch release management
Complaints handling
Investigation and root cause analysis
CAPA management
Quality management systems
Audit and inspection
Risk assessment
Change management
Deviation management
Annual product quality review
Self-inspection processes
Continuous improvement strategies
Data integrity assurance
SOP preparation
DECLARATION
I hereby declare that all information furnished by me in this document is accurate and true to the best of my knowledge and belief. Date: Uma sankar sahu
Timeline
Associate Manager
Novartis
09.2021 - Current
Assistant Manager
Dr. Reddy’s Lab. Ltd
03.2015 - 09.2021
Sr. Chemist
Mylan Lab. Ltd.
02.2012 - 02.2015
Jr. Officer
IPCA Lab. Ltd.
08.2010 - 12.2011
PSR
Ranbaxy and Nicholas Lab Ltd.
01.2008 - 01.2010
Bachelor’s - pharmacy
Biju Patnaik University