LATIKA PRIYADARSINI
Site Investigation Team Lead
Rench
Summary
Dynamic and results-driven professional seeking to excel in a competitive landscape, with achievements reflecting dedication and capability. Committed to leveraging skills and experience to overcome challenges and drive success in every endeavor. A proactive approach to problem-solving and a passion for continuous improvement ensure impactful contributions within the organization. Eager to embrace opportunities that foster growth and innovation while making a meaningful impact.
Multi-tasking Team Leader well-known for executing successful, new [Type] initiatives. Creates dynamic and positive workplace culture to align with organizational mission and values. Trains new hires and mentors struggling workers to achieve overall team success.
Overview
16
16
years of professional experience
1
1
Language
Work History
Team Lead-Site Investigation Team
Dr. Reddy’s Laboratory Ltd.,
01.2025 - Current
- Lead and direct the entire site teams for scientifically solving problems reported through deviations, OOS, OOT and market complaints. Provide timely resolutions and assess quality impact to enable release of good batches and maintain supply assurance. Liaison with QC, Production, Microbiology, Engineering, Warehouse and Supply chain teams to enable timely resolutions and improvement of turnaround times. Leading a team of 4 direct reportees and 8 parallel team members from various departments.
Team member-SIT (QA)
Dr. Reddy’s Laboratory Ltd.,
12.2021 - 12.2024
- Governance of Incident management at site.
- To ensure adequacy of investigation for Data analysis, interpretation, Root cause and CAPA
- To ensure compliance of SOP for closure of Investigation within timeline.
- To investigate the incident of category minor, major, critical by working closely with CFTs to arrive at appropriate Root cause, Corrective action and Preventive action etc.
- Perform comprehensive review and analysis of data, procedures to identify the potential root causes.
- To investigate OOS, OOT and Market complaint by working closely with CFTs to arrive at appropriate Root cause, Corrective action and Preventive action etc.
- To ensure utilization of correct tools & methods during investigation to conclude the investigation with assignable or probable cause.
- To ensure periodic review of incident & complaint trends to identify any chronic and repeat incidents/complaints.
- To ensure capability of SIT & CFT members for investigation procedure.
- Provide support during internal and external Audits.
- Governance of Gemba activity at site as a part of all time audit readiness.
- Working for reducing the TAT of investigation, increasing the % of confirmed root cause, prevention of repeated deviation as a part of investigation robustness program.
Sr. Executive-QMS
Sun Pharmaceutical Industries Ltd., Halol, Gujarat
10.2019 - 11.2021
- Leading Production QMS activities, handling a team of 8 members.
- Investigation of unplanned deviation, participation in cross functional investigation (OOS/OOT/market complaint, etc.), taking necessary corrective and preventive action and implementation of the same.
- Proposal and review of change control, preparation of change control review sheet, follow up for approval and timely implementation of the same.
- Preparation of risk assessment, justification, and rationale for closure/implementation of various QMS document like planned deviation, change control, CAPA, etc.
- Effectiveness review of change control and CAPA.
- Preparation of various study protocol in association with different QMS document.
- Preparation of different SOPs related to general production procedure/Equipment operation, etc.
Assistant Manager
Cipla Ltd., Goa
04.2013 - 10.2019
- Risk assessment of elemental impurities in drug products.
- Preparation and review of Annual Product Quality Review report.
- Co-ordination for and compilation of Quality metrics data, Quality management review report.
- Co-ordination for investigation of rejection of raw material and packing material: logging the rejection, rejection report preparation, intimation to Purchase/vendor management, participation in investigation and CAPA, closure of rejection.
- Ensuring the change control procedure (initiation, assessment of change, approval, close out and maintaining related log).
- Monitoring of stability programme.
- Co-ordination for Pharmacopeia implementation.
- Reply to queries and providing necessary information related to Annual Product Quality Review report and change control to Regulatory and customer.
- Participation in OOS/OOT investigation.
- Review of Quality Control document like stability testing form, stability summary, establishment of trend limit, Specification, etc.
- Monthly log review.
- Export order review, performing gap analysis between submitted dossier and current CMC of drug product, sending the batch related document to customer after execution of the order.
- Ensuring putting of data logger in consignment as per requirement, retrieval of data, compilation and review of data logger report, investigation in case of any abnormal observation.
- Issuance and maintenance of Standard Packaging Material Specification (SPMS).
- Active contribution in Audit preparation.
- Conducting Scheduled and SOP training and completing the related procedure.
- Co-ordination with Regulatory affairs(Filling the GMP questionnaire for registration and renewal purpose, providing product workability checklist, providing necessary information and document for registration, variation filing and renewal purpose, keeping track of post approval commitment) for product registration in USA, Europe, South Africa, Canada, Brazil, ROW countries.
- Co-ordination for giving response to deficiency received from various regulatory bodies.
- Co-ordination for giving self-inspection compliance.
- Review of Corrective and Preventive action(CAPA).
- Monthly and half yearly trending of Deviation.
- Co-ordination for compilation of MHRA interim report.
- Providing necessary quality information to Vendor management team.
- Co-ordination for technology transfer activity.
- Active participation for new commercial launch (Sharing registered document with other stake holder for initiation of gap analysis, review of gap analysis, completing the other formalities of commercial launch).
- Review of manufacturing investigation and root cause analysis.
Analyst-I
Apotex Research Pvt. Ltd, Bangalore
02.2012 - 12.2012
- Preparation of Standard Operating Procedure (General, Operation and Calibration).
- Initiating change control form for Quality Control department
- Preparation of Equipment qualification document like DQ, IQ, OQ, PQ and coordinating for qualification.
- Daily calibration of analytical balance, pH meter and conductivity meter in LIMS.
- Coordinating with QA department with respect to CCF, conducting training in Quality Control department, SOP effective, submission of documents for issuance of log books, work sheets, other document control copy.
- Ensure document control procedure
Officer, Quality Control
Micro Labs Limited, Hosur, Tamilnadu
05.2010 - 02.2012
- Analysis and reporting of Tablets and Capsules for Stability batches.
- Preparation of Certificate of Analysis, Analytical work record, Specification for Raw material, Packaging material and Finished products.
- Compilation of stability data.
- Preparation of questionnaires for training purpose.
- Validation of Excel sheet
- Coordinating for on-job and induction training of new joining
- Active contribution for Audit preparation
Education
Advanced Diploma - Pharmaceutical Quality Assurance Management
I.P.E.R
Pune01-2014
B. Tech - Bio Technology
I.A.S.E University
Bhubaneswar, Odisha01-2008
+2 (Sc.) - undefined
C.H.S.E
Odisha01-2004
10th - undefined
B.S.E
Odisha01-2002
Skills
HPLC (Agilent Technology, with Chemstation software)
Dissolution Tester (Electrolab)
UV & IR spectrophotometer
Disintegration Tester
Autotitrator
Automated Friabilator
Digital Polari meter
Interests
Reading Books
Seminar/Training attended
- Attended PDA training for Quality Risk management on Dec.22
- Attended workshop for Artificial intelligence/Machine learning in Dec.22
- Attended workshop for multivariate analysis using SIMCA on Jan.23
- Attended seminar on Regulatory expectation on occasion of 10th anniversary of PDA India chapter on Feb.23.
Declaration
I do hereby solemnly affirm that all the statement and information furnished above are true, complete and correct to be the best of my knowledge and belief. Sign: Place
Competencies
Have excellent communication skills, result oriented, hard working, sincerity towards work, willingness to learn, active and consistence in achieving set target and ability to lead the team.
Timeline
Team Lead-Site Investigation Team
Dr. Reddy’s Laboratory Ltd.,
01.2025 - Current
Team member-SIT (QA)
Dr. Reddy’s Laboratory Ltd.,
12.2021 - 12.2024
Sr. Executive-QMS
Sun Pharmaceutical Industries Ltd., Halol, Gujarat
10.2019 - 11.2021
Assistant Manager
Cipla Ltd., Goa
04.2013 - 10.2019
Analyst-I
Apotex Research Pvt. Ltd, Bangalore
02.2012 - 12.2012
Officer, Quality Control
Micro Labs Limited, Hosur, Tamilnadu
05.2010 - 02.2012
B. Tech - Bio Technology
I.A.S.E University
+2 (Sc.) - undefined
C.H.S.E
10th - undefined
B.S.E
Advanced Diploma - Pharmaceutical Quality Assurance Management
I.P.E.R