QA executive with 4 Years 10 months experience at GSK, Nashik

1. CURRICULUM VITTAE
SWAPNIL MAHADEV AGAWANE
Email id- swapnil15287@gmail.com
Contact no- +91-9970839950
Objective:
To pursue knowledge, sharpen my technical skills and make myself competent to face the global
challenges in the pharmaceutical industry. Looking for an organization where my previous work
experience coupled with the new working culture will aid in my professional development.
Professional Experience:
 Current Employer: GlaxoSmithKline Pharmaceuticals Ltd., Nashik (May 2012 – Current)
1) Current Designation: Quality Assurance Executive (April 2013 – Current)
Current Job Profile: Working as the Operational Quality executive at GSK-Nashik responsible for
compliance of cGMP and implementation of QMS principles on shop floor. Acting as a point of contact on
shop floor in quality related issues.
Key Responsibilities:
Audit management and Inspection readiness: To ensure that the activities on shop floor are in
compliance with regulatory and GSK-Quality Management System requirements also to ensure compliance to all
audit observations in a time bound manner.
Self inspection (L1 Audits): Responsible for performing self inspection in area of work and to provide
support to production for preparation of self inspection schedule and audit universe to aid the inspection
readiness in area.
Performance management: To attend daily performance management meetings at departmental level and
escalate issues related to quality and compliance and track down the actions related to quality and compliance
issues in performance meeting to take the follow up for compliance to findings.
Change control: To review and assess the change control proposal before implementation and to review the
implementation of activities as per change control.
Deviation, CAPA and Root cause analysis: To provide support in handling of deviations, determining root
cause and designing of sustainable CAPA and closure of CAPAs with verification.
Market complaints: To review the market complaints received and participate in investigation of complaints
received.
Risk assessment: To carry out the gap analysis and risk assessments as per the requirement.
LIC (Local inspection committee): To participate in LICs, prepare and circulate the minuets of meeting
swapnil15287@gmail.com | Ph: +91 9970839950 |Passport no.: H5002347
Address – 270. Sant Rohidas nagar, Kasba, Baramati, Dist Pune, 413102.

2. (covering discussion points, actions, and decisions) to the attendees.
Trainings: To impart training related to cGMP, status labeling, GDP, SOPs to production staff and to provide on
the job trainings to new joiners in OQ.
Batch disposition: To ensure release/rejction of bulk and finished products in BPCS system, meeting the
statutory and QMS requirements, to market (local and export).
Document Review: To review Master BMR / draft MFR, draft SOPs as per regulatory and QMS requirements.
Verification of SOPs (for in place in use), batch documents, area logbooks, validation, trial and testing protocols.
Periodic/Annual product review: To conduct Periodic Product Review as per the approved schedule. Inform
timely, the findings in PPR and ensure closure of the same.
Line Clearance: To perform independent verification of line clearance.
In process checks: To ensure random verification of on-line activities like in-process checks.
2) Quality Associate GlaxoSmithKline Pharmaceuticals Ltd., Nashik (May 2012-April 2013):
To liase with manufacturing, planning and operational quality for issuance of documents like BMR, BPR,
logbooks, registers, recording forms etc. Ensure all GMP documents are issued and archived in controlled
manner & record of the same is maintained. Management of documentation control room.
3) Project Trainee GlaxoSmithKline Pharmaceuticals Ltd., Nashik (Aug 2010-May 2011)
1. Responsible for preparation of Periodic product review for ointments, tablets at GSK Nashik.
2. Development and validation of Analytical method for simultaneous estimation of vitamins.
Key Achievements during Performance duties in GSK:
1. Alignment and set up of documentation cell at GSK.
2. Improvement of document (batch documents) retrieval system with traceability.
3. Harmonization of Log books across the site.
4. Active participation in implementation of GSK-QMS system via QMS track and trace.
5. Preparation of CAPA tracker and team site for CAPA tracker.
6. Implementation and improvement of Line clearance procedure along with QA verification.
7. Active participation in initiation of GPS system at GSK Nashik.
8. Achieved Zero Overdue status for Quality systems at GSK Nashik.
9. Capability development of production staff through coaching and training.
10. Highest number of batch release in one day.
EDUCATIONAL QUALIFICATION:
swapnil15287@gmail.com | Ph: +91 9970839950 |Passport no.: H5002347
Address – 270. Sant Rohidas nagar, Kasba, Baramati, Dist Pune, 413102.

3. Degree University Year Percentage
M. Pharmacy (Quality Assurance Techniques)
Sinhgad college of Pharmacy, vadgaon, Pune. Pune
2010-11 66.42%
B. Pharmacy Sinhgad Institute Of Pharmaceutical Sciences,
Kusgaon (Bk.), Lonavala
Pune 2008-09 65.83%
H.S.C. Tuljaram Chaturchand College, Baramati. Maharashtra 2003-04 72.17%
S.S.C MES High School, Baramati. Maharashtra 2001-02 84.20%
GATE 2009 Qualified
Key projects undertaken during Masters:
M. Pharmacy Dissertation Project: Development And Validation Of RP-HPLC Method For Simultaneous
Estimation Of Six Water Soluble Vitamins(Thiamine mononitrate, Riboflavin, Nicotinamide, Pyridoxine HCl, Folic
acid, Ascorbbic acid), Performed at GlaxoSmithKline Pharmaceuticals, Nashik.
CO-CURRICULAR ACTIVITY:
 Participation in UICT sponsored competition Young Innovators’ Choice Competition, held at UICT,
Mumbai.
 Poster presented on Nutraceuticals in INDIRA PHARMA ZEAL 2008 held at Indira College of Pharmacy,
Pune.
 1st
prize in Ad-Mad Competition at 59th
National Pharmacy week 2009.
 Participated in National Youth Conference on Initiatives of Change (IofC) 2011 at Panchgani.
References: Can be provided on request
I hereby affirm that the information in this document is accurate and true to the best of my knowledge.
Swapnil M. Agawane
swapnil15287@gmail.com | Ph: +91 9970839950 |Passport no.: H5002347
Address – 270. Sant Rohidas nagar, Kasba, Baramati, Dist Pune, 413102.