ANJU S NAIR
Compliance QA Auditor
Abu Dhabi
Summary
PROFESSIONAL SUMMARY: A dedicated and self-motivated individual with 9 years of professional experience in Quality Assurance, Clinical development (CRO), and QC Compliance. Major strength as a coordinator in Auditing, Quality management system, Document review, Compliance Verification, Data integrity assessment and Rectification, Audit Trail Verification of Lab Systems, and Internal Quality Audit/ Assessments. Involved in Data Integrity projects, SAP Plant Maintenance & Enterprise Asset Management System and IOT Project Management.
Overview
8
8
years of professional experience
8
8
years of post-secondary education
4
4
Certifications
1
1
Language
Work History
JUNIOR MANAGER (COMPLIANCE QA AUDITOR
Syngene International Limited
Bangalore
07.2021 - 09.2022
- Worked as a Compliance QA auditor for Instrument/Equipment Quality Check, calibration check, IQ, OQ, PQ qualification, validation documents, change control etc. for all the departments.
- Worked as a core team member in 2 projects. i.e., SAP Plant Maintenance & Enterprise Asset Management System Project and IIOT Project Management.
- Authorized to conduct Vendor audits, System audits and to accompany other QA auditors during the audits.
- Core member of audit management i.e., Plan and perform relevant audits, prepare audit reports, review CAPA plan generated.
- Responsible for the QMS of departments related to Bioanalytical Research Laboratory, Human Pharmacology Unit, Central Laboratory – viz. GLP and relevant guidelines, Data Management, and other supporting departments.
- Worked as a controller of Master SOP’s and Record control for issuance and retrieval.
- Authorized to participate in the Regulatory inspections and Sponsor audits.
QMS CORDINATOR (QUALITY ASSURANCE)-DQA EXECUTOR
Mylan Laboratories, R&D Center
Bangalore
11.2019 - 07.2021
- Worked as Document controller in QA and performed administrator role for access management of all standalone instruments and equipment.
- Coordination with External Service provider for storage & retrieval of the documents.
- Ensure compliance and controlled documentation system, record retention and Information services including electronic records retention processes in accordance with regulatory requirements.
- Perform assessment and closure of incidents, investigations and CAPA Pertaining to R&D, tasks related to CDC and review of logbooks belonging to R&D functions periodically.
QUALITY OPERATOR
Pfizer Healthcare India Pvt. Ltd
Sriperumbudur
02.2016 - 02.2019
- Worked as a core team member in DATA INTEGRITY PROJECT (from Dec-2017 to Feb-2019).
- Worked as an Analytical Quality Assurance reviewer (from Oct-2013 to Dec- 2017) for the review and Approval of analytical data packages of finished products (Injectable & Solid Orals), Raw materials, In-process, Stability samples, Packaging material & water documents and Reviewed calibration of data for water analysis.
Analytical Quality Assurance reviewer
Hospira Healthcare India Pvt Ltd
Chennai
10.2013 - 02.2016
- For the review and Approval of analytical data packages of finished products (Injectable & Solid Orals), Raw materials, In-process, Stability samples,
- Packaging material & water documents and Reviewed calibration of data for water analysis
- Regular review of data audit trails for QC application software connected to laboratory equipment and coordinated with customer/ regulatory inspections, which are held in QC laboratory
- Reviewed relevant electronic records for data audit trials and sample re- measurements for each data packet which was generated through Empower, computerized analytical instruments to ensure ongoing compliance prior to the data approval in SDMS (Scientific Data Management System)
- Managed quality assurance programs including on site evaluations, internal audit, and customer surveys and reporting all malfunctions to production executives and Cross Functional Teams to ensure immediate action.
Education
Master of Pharmacy - Pharmaceutics
Sankaralingam Bhuvaneswari College of Pharmacy
Sivakasi, Tamil Nadu 04.2011 - 04.2013
Bachelor of Pharmacy -
Ezhuthachan College of Pharmaceutical Sciences
Marayamuttom, Thiruvananthapuram, Kerala 01.2006 - 01.2011
AISSCE (12th) -
Kendriya Vidyalaya Pattom
Thiruvananthapuram, Kerala 04.2005 - 01.2006
AISSE (10TH) -
Kendriya Vidyalaya Pattom
Thiruvananthapuram, Kerala 04.2003 - 01.2004
Skills
Internal and External Auditing
CAPA Management
Audit coordination, Inspections, Reviews
Vendor management
Team work
Data integrity assessment and rectifications
Review of Lab Equipment/Instrument calibration verification
Document control, review and management
Microsoft office
Communication
Critical thinking
Training and development
PASSPORT DETAILS
PASSPORT NUMBER : R3215065
PASSPORT VALIDITY : 07/08/2027
VISA NUMBER : 204/2022/77921942
VISA VALIDITY : 19/01/2023
Personal Information
FULL NAME : Anju S Nair
DATE OF BIRTH : 1 Nov, 1988
LANGUAGES : English, Malayalam, Hindi, Tamil.
FATHER NAME : K Appukuttan Nair
MARITAL STATUS : Married
SPOUSE NAME : Akhil P G
CURRENT ADDRESS : Anju S Nair,
Villa No: 08, Al Raha Complex,
Al Madeenah Street,
Madinat Zayed, Western Region,
Abu Dhabi, Pin Code: 28669,
United Arab Emirates.
PERMANENT ADDRESS : Panikkassery[H],
Chappara, Pullut P.O.,
Kodungallur, Thrissur District,
Kerala State, Pin Code: 680663,India.
Certification
Trained on Data Integrity and Audit trails review from Parexel.
Regulatory Audits Faced
USFDA / MHRA / TGA / Health Canada / Indian FDA /ANVISA
Additional Information
INDUSTRIAL TRAINING EXPERIENCE
- Undergone industrial training for 6 months in Orchid Chemicals and Pharmaceuticals Ltd, Irungattukottai, Kancheepuram district, Chennai.
- Undergone industrial training for 1 month in Kerala State Drugs and Pharmaceuticals Ltd (KSDP), Kalavoor, Alapuzha, Kerala.
- Undergone industrial training for 1 month in Pharmaceuticals and Chemicals Travancore Pvt Ltd (PCT), Vanchiyoor, Thiruvananthapuram, Kerala.
HONOR AWARDS
2017 Q2 Mission Award for Audit trail review flow of Analytical Instruments and
Empower Applications.
Pfizer Healthcare India Pvt. Ltd.
CAREER OBJECTIVES
To secure a challenging position in a reputable organization to expand my learning, Knowledge, and skills. Secure a responsible career opportunity to fully utilize my training and skills, while making a significant contribution to the success of the company.
STRENGTHS
Responsibility, Punctuality, Originality, Open-mindness, Flexibility, Team-oriented, Success-oriented, Hardworking and the ability to work under pressure to meet deadlines.
Timeline
JUNIOR MANAGER (COMPLIANCE QA AUDITOR
Syngene International Limited
07.2021 - 09.2022
QMS CORDINATOR (QUALITY ASSURANCE)-DQA EXECUTOR
Mylan Laboratories, R&D Center
11.2019 - 07.2021
QUALITY OPERATOR
Pfizer Healthcare India Pvt. Ltd
02.2016 - 02.2019
Analytical Quality Assurance reviewer
Hospira Healthcare India Pvt Ltd
10.2013 - 02.2016
Master of Pharmacy - Pharmaceutics
Sankaralingam Bhuvaneswari College of Pharmacy
04.2011 - 04.2013
Bachelor of Pharmacy -
Ezhuthachan College of Pharmaceutical Sciences
01.2006 - 01.2011
AISSCE (12th) -
Kendriya Vidyalaya Pattom
04.2005 - 01.2006
AISSE (10TH) -
Kendriya Vidyalaya Pattom
04.2003 - 01.2004