Pharmacist RA officer, QA

ASWATHY SUSAN JOHN

INDUSTRIAL PHARMACIST; SCIENTIST

Regulatory Affairs & Compliance (RA), R&D-QA (Quality Assurance), Stability In-Charge & Product Development Technical Support of Pharmaceuticals, Personal /Consumer Care & Animal Health Products Total Experience: 6 Years & 8 Months

Looking for: Suitable opportunities

*******@*****.*** +971-********* United Arab Emirates CURRICULUM VITAE

WORK EXPERIENCE

01.03.2015 – 15.05.2018

SCIENTIST

RA (Regulatory Affairs), R&D - QA (Quality Assurance), Stability In- Charge & Product Development Technical Support Pharmaceuticals, Personal Care & Animal Health Products

At Himalaya Global Research Centre, Dubai, UAE

• Regulatory Affairs & Compliance (GSO, EU, MENA, GCC)

• Regulatory Dossier support: CTDs, PIFs, CPSRs, Artworks, COCs

• Label & Artwork Reviews

• Stability Studies: Planning, Coordination, Execution, Analysis & Documentation

• Quality Assurance Compliance, audits & Management systems

• SOPs & Trainings

• Document Control

• Product Development Technical Support

Achievements

Handled preparation and control of all R&D related Regulatory documents for registration of 34 products and more till date.

Developed & Implemented around 80 SOPs, which includes functional, Operational & Instrumental that ranges for Formulation, analytical, microbiology departments and trained all stakeholders on the successful implementation of the same.

Executed the stability studies of around 30 Personal Care & Pharmaceutical Products

OBJECTIVE

Waiting to explore opportunities in Regulatory Affairs / Quality Assurance/ Compliance/ IPQA/Scientific Research & Development/ Academics/ Market Research/Business

Development/Technical writing/Scientific offices in the Pharmaceuticals/ Personal Care & Cosmetics/ Animal Health/ Medical Devices/ Biomedicals/ Perfumes, Fragrances & Flavors/ Food/ Chemical Industry or any other relevant scientific field.

EDUCATION

TRAININGS & CERTIFICATIONS

April 2018

Level 4-The Principles of Food Safety Management for Manufacturing Training

Feb 2016 to July 2016

Industry Certification in Pharmaceutical Quality

Assurance and Quality Control

(Quality Council of India (QCI) Government of India Approved

& Certified), from IGMPI, New Delhi, India.

2009 to 2011

Master of Pharmacy, M. Pharm (Pharmaceutics)(2 years) From Vels University, Chennai, India (Vels School Of Pharmaceutical Sciences, CGPA – 7.01, OWAM - 79.38, Average % of marks- 78.57 %)

2004 to 2008

Bachelor of Pharmacy, B. Pharm (4 years),

From Rajiv Gandhi University of Health Sciences, Bengaluru, India (JSS College of Pharmacy, Mysore, Average % of marks

- 73.5%)

12.02.2012 to 24.02.2015

REGULATORY AFFAIRS EXECUTIVE - Pharmaceuticals

At Neopharma Llc., Abu Dhabi, UAE

• Pharmaceutical Regulatory Affairs & Regulatory Compliance

• Preparation of Dossiers & CTDs – MODULE 1, 2, 3, & 5 for UAE, GCC (includes SFDA, MOH- UAE), CIS & MENA markets

• Registrations and Renewals, Minor Change Approvals

• Handling PMFU Queries from Regulatory Authorities

• Artwork Reviews

• Leaflet Revisions & SmPC

• Review and compilation of all Registration Documents Achievements

Key Player in the regulatory submission dossiers for MENA & CIS countries

06.02.2009 to 23.08.2009

EXPERTISE

Regulatory Affairs & Quality Compliance

MOH/Municipality PMFU Queries

Regulatory dossiers & documentations

(CTDs, PIFs/CPSRs, NPD Registrations,

Renewals & Minor Variation Dossiers)

R&D-QA –Stability Studies, ICH

guidelines, Analytical Techniques

R&D- RAQA – Operations &

Documentations, GDP, Document Control

TRAINEE PRODUCTION CHEMIST - Pharmaceuticals

At Sangrose Laboratories Ltd, India

• Production & Packaging of Tablets, Syrups and Topical Preparations

SOPs & trainings

QA Compliance laboratory audits, GMP,

GLP

Product Development Technical Support

ASWATHY SUSAN JOHN

INDUSTRIAL PHARMACIST; SCIENTIST

Regulatory Affairs & Compliance (RA), R&D-QA (Quality Assurance), Stability In-Charge & Product Development Technical Support of Pharmaceuticals, Personal /Consumer Care & Animal Health Products Total Experience: 6 Years & 8 Months

Looking for: Suitable opportunities

*******@*****.*** +971-********* United Arab Emirates CURRICULUM VITAE

JOB RESPONSIBILITIES CARRIED OUT

REGULATORY AFFAIRS – AS EXECUTIVE

• Ensures Regulatory Compliance in New Pharmaceutical products Research and Development and for the Registration, Renewal and Minor Variations of pharmaceutical products in various countries as per the regulations laid down by the regulatory bodies of respective countries (mainly UAE, GCC, CIS, MENA)

• Preparation, review and submission of CTDs & dossiers for the registration of ethical pharmaceuticals, OTCs and Herbal products with international regulatory agencies as per the regulations and guidelines of respective country (UAE, GCC, CIS, MENA) (CTDs- MODULE 1, 2, 3 & 5 – For Generic Products)

• Reviewing art works and specifying storage, labeling and packaging requirements.

• Managements of MOH queries and PMFUs.

• Reviews and analyses all product documents and assist in validating the vendors based on the specification checklists.

• To co-ordinate with quality control and quality assurance professionals of principles and guide them about the requirement of quality control document required by Regulatory Authorities of different countries.

• Renewal of product registrations and manufacturing licenses.

• Variation applications: Labeling Changes, Artworks, Additional Pack Size Extension/reduction in shelf life, Changes including Manufacturing Process, Specifications & Analytical Procedures.

• Preparation and revision of leaflets for new and existing products

• Follow up with local agents in Gulf countries regarding pending issues.

• Tender related required regulatory documents.

• Update and maintain Information systems related to regulatory.

• Compile the manufacturing and quality Control parts of regulatory submissions made locally and regionally.

• Assist the Line manager in handling regulatory requirements related to the manufacturing needed for Marketing applications

• Inspections at local and regional level (stability, Specifications, In Process Quality Control, Artworks, Bulk specs).

• Ensure that all manufacturing aspects are in compliance with the Marketing Authorizations of the product

R&D - REGULATORY & QUALITY ASSURANCE COMPLIANCE -AS SCIENTIST 1) As R&D – Regulatory Affairs (RA) & Compliance; Scientific &Technical Dossier Support

• Ensures Regulatory Compliance during development and ensure timely Registration support for newly developed products

• Preparation and compilation of all registration documents and dossiers including CTDs, PIFs, CPSRs required for registration of Pharmaceuticals and Personal /Consumer Care and Animal Health Products.

• Compiles and reviews all RA related documents for R&D

• Scientific and Document support for R & D for product registration 2) As R&D – Quality Assurance (QA) For Pharmaceuticals & Personal Care Products a) R&D -QA – Compliance, Operations & Documentation Specialist

• Preparation and implementation of all SOPs and conduct trainings to the employees on the same.

• Quality Compliance for R& D – GMP, GDP & GLP

• Contribute to R&D team for updating with protocols, SOPs & other processes. ASWATHY SUSAN JOHN

INDUSTRIAL PHARMACIST; SCIENTIST

Regulatory Affairs & Compliance (RA), R&D-QA (Quality Assurance), Stability In-Charge & Product Development Technical Support of Pharmaceuticals, Personal /Consumer Care & Animal Health Products Total Experience: 6 Years & 8 Months

Looking for: Suitable opportunities

*******@*****.*** +971-********* United Arab Emirates CURRICULUM VITAE

• Auditing labs for QA compliance, notebooks and data management including deviations, CAPA

• Preparation, Review, Revision and Distribution of all QA documents such as PDRs, MFRs, and COAs.

• Preparation, Review and analysis of all Technology transfer documents including BMRs, BPRs, SOPs, PDRs, MFRs, Composition Certificates COCs, COAs for Pharmaceuticals, Personal Care & Animal Health Products

• Co-ordinate with all stakeholders for RA QA document related queries

• Document Control of all QA documents such as instrumental log sheets, Calibration data sheets, audit reports etc b) Quality Assurance Stability Studies In-charge

• Planning, Coordination & Execution of Stability studies as per protocol

• Responsible for establishing a Stability program as per the Stability protocol and ensures the following of the same in the study

• Ensure that the testing of all products has been performed as per the standards guidelines (ICH/FDA/GCC and WHO)

• Initiation of the stability studies & tracking the samples, withdrawal & analysis as per the specifications on the due dates

• Responsible for collection, verification & compilation of stability reports & Maintaining stability records and Logbooks.

• Accountable for the OOS Investigations and reports

• Ensures the proper working of the stability chambers and storage conditions in the same. c) R&D – Product Development -Technical Support

• Carry out Product Developmental Studies such as

• Preformulation Studies

• Excipient Compatibility Studies

• IPQC checks during development

• Assist principle scientist in all key functions of product development.

PRODUCTION, PACKAGING & IPQA – AS PRODUCTION CHEMIST

• Manufacturing and Packaging of Various Pharmaceutical Dosage Forms (Tablets, Syrups, Hard Gelatin Capsules, Topical Preparations).

• In process Quality Assurance – IPQA (For Tablets, Hard Gelatin Capsules and Syrups).

• Preparation of Documents (BMR, MFRs, PDRs).

COMPUTER AND I.T ACQUAINTANCE

• Programs: MS word, MS Excel, MS PowerPoint, MS Outlook ADMINISTRATION & OFFICE MANAGEMENT SKILLS

• Document Control, Coordination and distribution

• Record Keeping of activities

• Training Records of employees

• Management of all departmental files

• Letters, Declarations and other written and oral communications

• Printers & scanners operations

PERSONAL DETAILS

Visa - Husband’s Sponsorship Availability- Immediate

Driving License – India, UAE Born on - 03/01/1986

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