Trackwise
Palak Suthar
QA Associate
Sydney,NSW
Summary
QA Associate eager to contribute through hard work, attention to detail, and, excellent organizational skills. Clear understanding of quality and regulatory affairs and guidelines. Motivated to learn, grow and excel in pharmaceutical industry.
Overview
4
4
Certifications
8
8
years of post-secondary education
7
7
years of professional experience
Work History
QA Associate
CONTRACT MANUFACTURING AND PACKAGING SERVICES PVT. LTD, PINNACLE, SYDNEY
Smithfield, NSW
08/04/2 - Current
- Individually handling QMS department in company.
- Initiate and evaluate the change control related to formulation changes, commissioning of new equipments, modification of facility, implementation of new software (LabSolution CS) in laboratory with audit trail and electronic name/signature.
- Initiate and evaluate deviation related to manufacturing process, equipment breakdown, non compliance of finish good batch with release specification as per TGO 101 & TGO 100.
- Initiate and evaluate OOS related to raw material, in-process and finish goods. Recommending CAPA and monitored for compliance.
- Handling deviations and non-conformances, change control, complaints, recalls and returns , OOS and OOT, CAPAs, self-inspection and quality risk management.
- Drafting of Product Quality Reviews (PQRs) for listed and complementary medicines according to the PIC/S Guide to Good Manufacturing Practice for Medicinal Products (PIC/S Guide to GMP).
- Total 15 PQR prepared (For year 2019-2020) with Product specific pathway by reviewing all 12 main points ( Deviations and non-conformances, Change control, Complaints, recalls and returns , OOS and OOT, CAPAs, Self-inspection, Stability, Vendor assurance, Validation and qualification, Quality Risk Management, Contractual agreements ) described in PIC/S guideline with thorough explanation by Bar chart, Line chart and Pareto chart for all quality attributes.
- Evaluate total 75 products (with no adverse event) using review by exception pathway for product quality review.
- Got appreciation from higher authority for drafting and managing approval of reduce testing of total 5 legacy product (softgel capsules, film coated tablets) at in-process stage with scientific rational justification, risk identification, evaluation and mitigation.
- Handling CSV project (Off the self software Labsolution CS) as part of QA Internal Auditor for TGA audit compliance year 2019 to implementation of electronic name/signature.
- Established standard operating procedure of audit trail review, management of user credential and user access level allocation.
QMS Executive (International Bussiness Unit)
Alembic Pharmaceuticals Limited Panelav Plant
Vadodara, Gujarat
04.2018 - 02.2020
- Hired as SME for investigation of solid dosage forms (modified release, controlled release tablets and capsules) exported to United States.
- Lead a team of 13 people for compliance of regulatory inspection (USFDA) carried out in year 2018 for re-investigation of failure of exported batches to meet required specification.
- Re-investigated total 140 (2016), 129 (2017) & 30 (2018) out of specification (raw material, in-process and finish product) for US marketed drug products for dissolution, assay, content uniformity and related substances and re-submit to USFDA.
- Re-investigated deviation related to production and packaging operation which are failed to support root cause through scientific justification and re-submit technical justification to USFDA.
- Got appreciation from manufacturing science and technology head for drafting and evaluating critical process parameters and ranges there of for bi-layered tablet (Telmisartan+Hydrochlorothiazide bi-layered tablet).
- Investigated out of specification and out of trend analytical results using Ishikawa and 6M approach with recommending CAPA for future batches and manufacturing deviation & root cause identification using peel the onion, 6M, 5 why, fault tree analysis and FMEA.
- Involve in lean implementation, process gap identification.
Technical Assistant (Tablet)
Torrrent Pharmaceutical Ltd.
Ahemdabad, Gujarat
11.2014 - 03.2018
- Initiate change control by identification of changes, nature of changes and allocating category of change, evaluation of changes, implementation of action and post changes review in TRACKWISE software.
- Tracking of child related to each change control and closure in TRACKWISE software.
- Drafting of recipe & BOM in SAP for new products and resource allocation (e.g. Man, Material, utility and equipments).
- Drafting of batch manufacturing record for solid oral dosage form (Film coated tablets, Sugar coated tablets, Enteric coated tablets, Hard gelatin capsules) and MUPS (Multi unit Pellet system) with Glatt FBP - GPCG 300 ,german coater, Fette 2090i compacting machine and bi-layered tablet compression machine.
- Reviewing the batch manufacturing record of validation batches for addition of modified RMG granulator top lid with sprinkler as PAS change in CBE 30 filling.
- Lead the 250 BMR revision project including allocation of work, tracking and completion of all the changes related to changes for excipient quantity, code and description and other minor changes.
- Drafting of master formula card from technology transfer information document and maintain time to time uploading of document in document control system.
- Drafting of process validation protocol as per CGMP regulations for validating pharmaceutical (drug) manufacturing of meeting all the attributes they are intended to possess (21 CFR 211.100(a) and 211.110(a)), ICH Q8R2, EMEA guideline of process validation and ISPE guideline on process performance qualification.
- Follow up for process validation protocol and report with production supervisor and establishing roles and responsibility of various functional group, sampling and testing strategy, data analysis method(e.g. statistical process control), strategy for handling OOS, OOT results.
QA Officer
Ratnamani Healthcare Pvt Ltd.
Indrad, Gujarat
04.2013 - 11.2014
- Drafting standard testing procedure from default standard like IP, BP and USP.
- Drafting of SOP for QA, QC, production and engineering department.
- Issuance of document like BMR, BPR, SOPs, change control and distribution, archival of superseded document.
- Co-ordination with production and quality control for validation of new products.
- Managing training calendar and matrix after assessing individuals training needs and maintaining all the training records.
- Managing the quality systems in line with the regulatory requirements.
- Evaluation and closure of deviation, change control with proper documentation
QA/QC Officer
Cambridge Healthcare Pvt. Ltd.
Mehsana, Gujarat
09.2012 - 04.2013
- Chemical analysis of raw material, bulk product, in process sample & finished product samples and involve in preparation & review the certificate of analysis.
- Perform calibration/validation of lab instruments as per schedule. chemical analysis of raw material and finished product samples by UV/V spectrophotometer, hands on operation of moisture balance, polarimeter, vacuum oven, refractometer, Karl Fischer.
- Prepared standard testing protocol, standard specification as per IP, BP and USP.
Education
Regulatory Affairs Certification : Pharmaceutical (Regulatory Affairs Professional Society) - Regulatory Affairs
RAPS Online University
Online 10.2020 - 03.2021
Bachelor of Pharmacy - Pharmacy
Gujarat Technological University
Ahemdabad 07.2008 - 07.2012
HSC -
The New Progressive Highschool
Mehsana 07.2006 - 07.2008
SSC -
Saraswati Vidya Vihar
Mehsana 07.2004 - 07.2006
Skills
Quality assurance inspections
Strong understanding of the cCMP’s with working knowledge of US FDA, 21 CFR part 210 and 211 and EU GMP requirements
Document interpretation and review
Audit compliance
Lean manufacturing and quality systems
Quality management system compliance
Excellent risk assessment abilities
Passionate about root cause investigation
Familiar with root cause analysis tools like "Pareto Chart", " 5 Whys", "Fishbone Diagram", "Scatter Plot Diagram", "Failure Mode and Effects Analysis (FMEA)"
Good interpretation skill with TGA regulatory guidelines
Knowledge about Pharma 40 program
Accomplishments
- Collaborated with team of 13 in the development of CPP evaluation project as part of compliance.
Affiliations
- Member at RAPS - Regulatory affairs professional society.
- Industry Member of ISPE - International society of professional Engineering.
Certification
Certified Lean Six Sigma Green Belt (Exemplar Global ) Credential ID: G201914968
Software
SAP
LabSolution CS
Documentum
Document control System
LIMS
Jira
Confluence
MiniTab
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Additional Information
I am very passionate to learn new things and upcoming trend. I am active member of ISPE. ISPE give me best platform to learn about ISPE Pharma 4.0 SIG and working groups.
Timeline
Regulatory Affairs Certificate: Pharmaceuticals
03-2021
Regulatory Affairs Certification : Pharmaceutical (Regulatory Affairs Professional Society) - Regulatory Affairs
RAPS Online University
10.2020 - 03.2021
Six Sigma Statistics using Minitab 17
09-2020
Certified Lean Six Sigma Green Belt (Exemplar Global ) Credential ID: G201914968
09-2019
QMS Executive (International Bussiness Unit)
Alembic Pharmaceuticals Limited Panelav Plant
04.2018 - 02.2020
Vendor Managment
11-2017
Technical Assistant (Tablet)
Torrrent Pharmaceutical Ltd.
11.2014 - 03.2018
QA Officer
Ratnamani Healthcare Pvt Ltd.
04.2013 - 11.2014
QA/QC Officer
Cambridge Healthcare Pvt. Ltd.
09.2012 - 04.2013
Bachelor of Pharmacy - Pharmacy
Gujarat Technological University
07.2008 - 07.2012
HSC -
The New Progressive Highschool
07.2006 - 07.2008
SSC -
Saraswati Vidya Vihar
07.2004 - 07.2006
QA Associate
CONTRACT MANUFACTURING AND PACKAGING SERVICES PVT. LTD, PINNACLE, SYDNEY
08/04/2 - Current