SHANTALA Y.M.

Contact: +91 8050520878 E-Mail: shantalaym@gmail.com

Seeking challenging assignments in Quality Assurance Department/ Regulatory Affairs / Project
Management / Audits in Pharmaceutical Industry
Abridgement

An astute professional with over 8 years of industrial experience and established success in
Corporate Quality Assurance and Regulatory Affairs which includes
o

Implementation of Quality Management System, Documentation control, Self-inspection

system to check the GMP/GLP/ Quality compliance, Vendor qualification, Training of
personnel , Handling client audits and regulatory inspections.

Review, gap analysis and Dossier Compilation (Regulatory and QA)

Possess sound understanding to effectively & timely completion of projects & working out various
requirements with respect to strategic planning, vendor quality standards, coordinating with cross
functional teams and planning of resources.
Distinction of implementing Quality Management System to achieve process quality excellence.
Mapping project requirements from developing to implementing effective processes in line with set
guidelines/procedures.
Excellent communication & analytical skills with strong organizational and team building abilities.

Skill Set
Project Management

Management review meetings

Internal and External customer Audits

SOP and Technical writing

GMP/GCP/GLP audits

Investigation of market complaint,

Process Planning & design

Deviations & Change control of GMP

Quality Risk Assessment

pharmaceutical unit (OSD and parenteral)

Employment Scan
Since January 2013 with PharmaLeaf India Pvt. Limited, Bangalore
Current Role: QA&RA Compliance Consultant (Part time)
Job Role:
To drive a quality culture through the established systems to ensure that the services meet the
necessary expectations and regulatory requirements.
Improve operational quality across the organisation.
Promote continuous improvement.
Conduct quality audits and report results.
Participate in and represent Quality in operational meetings
Ensure compliance with company and customer quality policies.

 Build and manage the relationship with external agencies and business partners.
Report on audits and non-compliance issues / improvement recommendations.
Host External Audits.

June 2010 October 2012 with PharmaLeaf India Pvt. Limited, Bangalore
Role: Associate Manager QA & RA
Job Role:
Project management and communication with stake holders
Technical writing (SOP, policy writing) for in-house and clients
Quality Review of regulatory submissions review to check the compliance to product
requirements in regulated and ROW markets ( Review of clinical submission and CTDs)
Develop regulatory strategy
GMP/GCP (Site feasibility) / Vendor Qualification audits
Handling Client audits independently
Co-ordination with liaison for submission, query and approval
Maintenance and archival of clients documents
Develop training modules for in-house resources as well as for clients
May 2008 to June 2010; Micro Labs, Bangalore
Role: Corporate Quality Assurance officer
Job Role:
Maintenance and implementation of overall Quality Management System for all the site (14 sites)
Vendor qualification for raw materials
Preparation for regulatory inspections
Conducting self-inspection
Handling change control; market complaints, deviations & incidents
Maintenance of stability studies as per set stability protocol and procedures
Compliance to regulatory queries
Tracking of calibration and qualification schedules.
Product and process risk analyses

July 2007 to April 2008, SGS India Pvt. Ltd., Chennai

Role: Branch Quality Assurance Co-ordinator
Job Role:
Maintenance of GLP requirements as per ISO 9001 (Quality Management System) and ISO 17025:
2005 (Laboratory requirements)
Conducting port inspections and audits as per clients request
Handling management review meetings
Documentation controller
Self-inspection
Analyst qualification
Handling internal and external audits

June 2006 to July 2007, FRLHT, Bangalore

Role: Junior Research Fellow
Job Role:
Maintenance of lab documents as per ISO 9001 requirements

Microbial analysis of water samples and Ayurvedic drugs

Physical and chemical analysis of Ayurvedic drugs
HPTLC of Ayurvedic drugs
Report compilation

Academia
Masters in Microbiology from Sri Bhagwan Mahaveer Jain College, Bangalore in 2006. Secured
70.2% marks.
Executive MBA (specialization in Project Management) from Alliance University, Bangalore
completed in October 2012
Bachelors in Chemistry, Zoology and Microbiology from Mount Carmel College, Palace Road,
Bangalore completed in 2004 . Secured 72.03%
PUC (PCMB), from Adarsha College, RT Nagar, Bangalore completed in 2001, Secured 78%
SSLC, from VVS Sardar Patel School, Bangalore, completed in 1999, Secured 85.6%
Honors and courses
Diploma in Intellectual Property Rights (PGDIPR) with Grade A at National Law School,
Bangalore. Submitted a project titled Pharmaceutical Patenting in India and its Public Access to
Health in 2007
Short term training programme in Survey of Medicinal Plants & Pharmacognosy by Regional
Research Institute (Ay), C.C.R.A.S., Bangalore in December 2006
IT Purview
Operating Systems
Office Applications
power

: Windows 98, 2000 professional, XP & Vista

: MS office 2003, 2007. MS Project. Good Hands on experience in Excel &
point.

Personal Dossier
Date of Birth
Gender
Marital Status
Contact Number

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18th Sep 1983

Female
Married
Mobile: 8050520878

Annexure of Academic Projects Handled

PROJECT DURING EXECUTIVE MBA
Title: Project Management of pharmaceutical regulatory projects through the software MS
project
Objective:

Project management of outsourced generic drug development projects in India

Ensure that the project is complaint to global regulatory standards
Use of MS project software as a tool in effective handling of the projects in terms of scope,
time and quality of the deliverables.

The methodology discussed in the project is specific to project management of outsourced

development of generic oral formulation in India. The dossier generated will be ready to file
dossier for filing in regulated markets (ICH eCTD dossier)

PROJECT HANDLED DURING M.Sc.

Title: Screening and Identification of Potential Fungal Strain/s for the Production of Extra
cellular
Alkalophilic Lipase.
Description: Isolated a Fungal strain (Mucor sp.) by the rapid screening technique (Rhodamine B
method) and then tested this fungal strain for the production of Alkaline lipase by
paraNitroPhenylPamitate (pNPP) assay method.
Presentation: Presented this work at the 32nd Annual Meeting Of The Mycological Society Of India,
National Seminar on Fungal Biodiversity, Biotechnology and Bioinformatics, held on 2nd and 3rd of
February 2006.
Publication: The paper has been accepted and published by African Journal of Biotechnology