Shanthi Prakash Jain
Mississauga,ON
Summary
Multi-talented Associate Director with over 18 years of robust pharma industry experience. Focused on streamlining operations, building quality and efficiency. Mentors and coaches staff to optimal levels of productivity and to meet deadlines. Adds value to any organization in need of great collaboration, interpersonal and multitasking abilities. Meets tight deadlines.
Overview
20
20
years of professional experience
1
1
Certification
Work History
Associate Director, Clinical Quality & Compliance
AstraZeneca Canada
Missanabie, ON
02.2023 - Current
- Delivery of Quality Management activities related to clinical development within R&D, working with stakeholders across the business to embed quality/compliant practices while leading and guiding proactive inspection readiness activities within Clinical Operations and other Clinical R&D functions
- Supporting the Biopharma Clin Ops functions in Quality and Compliance related systems and tools (PowerBI, VQV).
- Crossfunctional collaboration with quality and compliance functions (R&D SAT Quality Assurance, Oncology compliance team, Alexion compliance team, Audit compliance team etc).
- Oversight of quality scorecard and Key Quality Indicators (KQI) for the V&I, Early Oncology, Global Clinical Solutions and PQBC functions. Provided guidance and support to the functions on achieving the metrics.
- Providing guidance and support to the primary assigned functions on Quality Issues management, CAPA management and effectiveness checks in VQV.
- Supporting the primary functional partners and department quality leads in reviewing the training documents, SOPs, WIs and guidance documents.
- First line of support to the assigned functions on quality issues, complaints, and questions regarding processes and regulations (GCP, GCLP, GDP etc.).
- Supporting the primary functional partners and relevant functions staff in inspection readiness preparation (BIMO checklist review, Mock inspection participation etc.)
- Regular quality meeting with assigned functions, quality oversight updates on quality issues, CAPAs, performance on KQIs etc.
- Assisting the leadership team with identifying and implementing continuous improvements by collating including reporting quality related trends and metrics periodically.
Quality Compliance Specialist
Baxter International Inc.
Toronto, Canada
03.2020 - 02.2023
- Introduced weekly and monthly metrics reporting to laboratory quality management
- This helped to track and close all the controlled forms and environmental Monitoring Groups (MG) from 2019 to 2020
- The monthly open MGs from 1400 in Mar 2020 has been reduced to 115 in 2021 (91% reduction).
- Ensuring timely completion of CAPAs, NCRs and Change Controls in Trackwise system.
- Pulling metric data, trending and tracking of controlled forms, CAPAs, BaxLIMS monitoring groups, batch release data etc.
- Investigation of OOS, OOL and NCRs in Microbiology
- Decreased the number of OOLs by 78% from 2019 to 2020 1330 vs 283) by implementing effective CAPAs.
- Provided guidance to staff on regulatory requirements, policies, and procedures.
- Assisted in developing strategies for improving overall compliance performance.
- Performed risk assessments to identify areas of non-compliance and potential risks.
- Prepared monthly reports on progress made towards meeting organizational goals around compliance matters.
- Provided support to department by assisting with special assignments and projects.
- Worked with cross-functional teams to achieve goals.
Quality Compliance Supervisor
Apollo Health and Beauty Care
Toronto, Canada
07.2018 - 02.2020
- Prepared the trend data for audit findings, CAPAs, deviations, Complaints etc
- And reported to management.
- Scheduled internal audits, conducted those audits as a lead auditor and verified compliance for GMP Health Canada and FDA regulations
- Reported findings to internal stakeholders and improved the quality production processes.
- Investigated the out of specification results and deviations, proposed CAPAs and tracked them for completion in paradigm database.
- Completed the annual product quality review reports with the summaries for 8 product codes and was recognized for this effort.
- Coordinated with outside consultants when needed to ensure regulatory compliance.
- Analyzed data from laboratory tests to detect any discrepancies between expected results and actual outcomes.
- Investigated customer complaints related to product quality or safety, and recommended corrective action plans.
- Conducted periodic audits of manufacturing facilities to identify non-compliance issues and areas of improvement.
- Monitored production operations for compliance with good manufacturing practices and regulatory requirements.
- Built positive working relationships with other department managers through effective communication.
- Established key performance indicators that measure the success of quality initiatives.
- Reviewed standard operating procedures or quality assurance manuals to refine production processes or update for conformity to new regulations or policies.
- Created and managed training classes to educate new hires and existing employees about compliance concerns.
Remote Clinical Site Monitor and Process Optimization Specialist
PPD
Bangalore, India
10.2015 - 02.2018
- As a part of the project management team, remotely monitored five (5) global studies for ICH-GCP compliance and reported protocol deviations to Clinical Trial Managers (CTMs) and Clinical Research Associates (CRAs).
- Collected the clinical monitoring data from EDC, Medidata Rave and CTMS database, prepared the trend charts, reviewed key risks and quality indicators and provided regular updates to study team management.
- Globally trained and mentored seven (7) six sigma inter-departmental project teams for continuous process improvement using DMAIC cycle, Lean tools and certified team members for yellow belt.
- Improved processes and cost savings of about 200,000 USD per annum from the three (3) six sigma projects.
- Worked with cross-functional teams to achieve goals.
Senior Quality Assurance Auditor (Assoc. Manager)
IQVIA Asia Pacific
India and Singapore, India and Singapore
06.2007 - 06.2013
- Hosted numerous client audits/regulatory inspections across Asia Pacific central laboratory sites.
- Supported and facilitated the team in performing the quality issues and complaints investigation, root cause analysis and establishing Corrective and Preventive Actions (CAPAs) for deviations and audit findings and tracked them to closure in Trackwise.
- Collaborated with cross-functional teams to develop best practices for quality assurance programs.
- Conducted various Internal and external laboratory process and system audits across Asia Pacific region (Japan, China, Singapore and India), trained new hires and QA auditors on audit methodology and audit CAPA response.
- Highlighted compliance issues for management team after conducting mock regulatory inspections.
- Managed and trained team members to enhance audit department performance and increase operational efficiency.
- Prepared reports outlining audit findings and proposed solutions.
- Provided guidance and mentorship to junior Quality Assurance staff members.
- Organized team activities to build camaraderie and foster pleasant workplace culture.
- Acted as QA representative for management quality review meetings and provided updates for quality and regulatory compliance.
Quality Control Officer - Pharmaceuticals
Zydus Cadila Healthcare, FDC drugs and Kemwell biopharma
India, India
02.2004 - 06.2007
- Analyzed drugs (liquid dosages, solid dosages, bulk and raw materials) for microbiological quality parameters and reported to management.
- Performed Rabies and Typhoid vaccine testing, pyrogenic testing and safety testing
- Performed environmental monitoring of the manufacturing area and provided feedback to the management team on the microbial quality of the area.
- Participated in technical trainings and workshops to improve skills set and boost overall knowledge.
- Interpreted test results, compared to specifications and control limits and recommended data for release.
- Conducted routine and non-routine analyses of in-process materials or stability samples.
- Calibrated, validated or maintained laboratory equipment.
- Participated in internal audits conducted by third party auditors or customers' representatives.
- Conducted inspections of raw materials, components and finished products to ensure compliance with established quality control procedures.
- Maintained lab cleanliness and safety standards.
- Conducted tests on product samples and recorded results.
Education
Post Graduate Certificate - Pharmaceutical Regulatory Affairs And Quality Operations
Seneca College At York University
Toronto, ON12.2019
Master of Science - Microbiology
Mangalore University
Mangalore05.2003
Associate of Applied Science - Elements of Artificial Intelligence
University of Helsinki
trueSkills
- Rootcause Analysis
- Quality Issues and CAPA process management
- Team work and collaboration
- Hosting regulatory inspection and client audits
- Data reporting through various trend charts
- Communication and coordination
- Process Improvement
- Project Management
Certification
- FDA Clinical Investigator Training certificate (By Training and Continuing Education - FDA) - Dec 2023
- Principles and practices of Clinical Research by National Institute of Health (NIH) - Aug 2023
- American Society for Quality (ASQ) - Quality Manager / Organizational Excellence (07/2019 - Present)
- ASQ Certified Six Sigma Green Belt (11/2017 - Present)
- ASQ Certified Quality Auditor (12/2017 - Present)
- Barnett GCP Certificate (11/2011 - Present)
Timeline
Associate Director, Clinical Quality & Compliance
AstraZeneca Canada
02.2023 - Current
Quality Compliance Specialist
Baxter International Inc.
03.2020 - 02.2023
Quality Compliance Supervisor
Apollo Health and Beauty Care
07.2018 - 02.2020
Remote Clinical Site Monitor and Process Optimization Specialist
PPD
10.2015 - 02.2018
Senior Quality Assurance Auditor (Assoc. Manager)
IQVIA Asia Pacific
06.2007 - 06.2013
Quality Control Officer - Pharmaceuticals
Zydus Cadila Healthcare, FDC drugs and Kemwell biopharma
02.2004 - 06.2007
Post Graduate Certificate - Pharmaceutical Regulatory Affairs And Quality Operations
Seneca College At York University
Master of Science - Microbiology
Mangalore University
Associate of Applied Science - Elements of Artificial Intelligence
University of Helsinki
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