• Gender: Female
• Age: 27
• Designation: Manager Quality Assurance
• Highest Education Level: Post Graduate Diploma
• Preferred Country: India
• Notice Period: 30  Days
• Preferred Location: Mumbai
• Work Experience: 15.9 Year(s)

Education

Post-Graduation Diploma from Clinical Research CAHS (Ruia College)

ISO 9001:2015 from Lead Auditor SGS India Pvt. Ltd.

Office safety training from BSI

Six Sigma Black Belt from Grey Campus

T.Y. B. Sc. from Mumbai University (Patkar College)

Skill Sets

KEY SKILLS
Quality Assurance.
ISO 9001:2008, 9001:2015, 15378:2015.
Cold chain manage as per customer requirements
Customer focused.
Customer feedback
Knowledge of Quality Management.
Packing Development
Six Sigma Green Belt and Black Belt
Systematic and methodical.
Communication and Presentation skills.

Areas of Expertise
Audit – Internal, Customer, Regulatory- ISO 9001:2008, 9001:2015, 15378:2015.
Documentation & System Updation. Waste elimination.
Waste elimination.
COMPUTER PROFICIENCY
Having exposure to INFOR system.
Adequate exposure to MS Office.
ISO 9001:2015 certified from SGS India Pvt. Ltd.
Successfully completed Training for ‘Internal Auditor’ as per ISO 15378:2011
Guidelines.
Six Sigma Green Belt and Black Belt certified.

Work Experience

Designation : Manager Quality Assurance
From : Feb 2019 to Till date
Company Profile : Distributor Of (Proctors & Gambol . Appliances, Electrical, and Electronics Manufacturing.

Job Profile :
DOCUMENTATION
To maintain logistic documents like IRA, STN.
Maintain the product in appropriate manner.
Maintain product in cold chain as per standard.
Maintain FEFO system.
To prepare and review Standard Operating Procedures (SOP), Site Master File (SMF).
To prepare sample folder for customer reference.
To prepare and review Specifications, Testing Methods & other Quality Management
System documents off oil and carton printing.
Review of technical agreements, questionnaires for new & existing customer development.
To prepare and review of Drug Master File prior to submission & LOA for US FDA & Canada.
To prepare and review of Process & Quality Manuals required for various audits.
Reviewing Change controls, Deviations, Investigations, Out Of Specification & Market complaints.
Review & ensuring the execution of Corrective Action & Preventive Action (CAPA), Action
Plan effectiveness at plant level.
AUDITS
Conduct Global audits.
Conducting & participating internal quality audits as an Internal Auditor & preparing the audit/non-conformity reports.
Representing on behalf of management team during various Customer & Surveillance
audits.
PRODUCT RELEASE
Manage & maintain the company quality inspection & product release programs for
incoming & in-process materials & components, processes & finished goods.
Agreeing standards & establishing clearly defined quality methods for the users to apply
VENDOR DEVELOPMENT
Review vendor/suppliers performance & evaluation of the material supplied &recommended grade of vendor/supplier to the organisation.
Working with Purchase team to establish quality requirements from external suppliers.
Participate with Purchase team for New/Existing Vendor Site Audit.
ARTWORK & LABEL DESIGN MANAGEMENT
Review & Participating for the design, artwork & shade cards for the New/Existing products
Preparing sample folder for new customer of new products.
Professional
Experience in logistic FMCG company as P&G distributor and handle Merck Pharma product in cold chain activity .
Experience of working within a Quality Management System in the primary and secondary packaging manufacturing industries.
Fully conversant with all relevant Quality Assurance procedures.
Analysing problems and detecting the root cause of an issue by using latest QA methodologies.
Knowledge on ISO 22000
14 years experience in Quality Assurance dept. in Pharma Packaging industries and Supply chain logistic industry.
Having exposure to ISO (9001, 15378 Series) audit experience & DMF Submission.
Working for ISO 9001:2015 Guidelines as a Lead Auditor

Designation : Manager Quality Assurance & Quality Control
From : Oct 2017 to Feb 2019
Company Profile : Self Adhesive Lables, Cartons, Packaging Boxes, Paper Bags, Paper Cups.

Designation : Executive Management System ISO
From : Oct 2016 to April 2017
Company Profile : Krishna Antioxidant Pvt. ltd.

Designation : Manager Quality Assurance & Quality Control
From : March 2016 to Sept 2016
Company Profile : Metakaps Engineering Company Pharma Flexible

Designation : Corporate Quality Assurance Senior Executive
From : Oct 2011 to Feb 2016
Company Profile : ESS DEE ALUMINIUM LIMITED, MUMBAI

Designation : Quality Control - Executive
From : Dec 2009 to Oct 2011
Company Profile : AMARTARA PVT. LTD.

Future Goals

To work with an organisation which has customer focus approach and faith in management systems for establishing improvements, and provides an environment for acquiring and practising innovative skills for individual development.