Quality Executive

SARADHARA RAHUL PMP®

CONTACT NO : 077********

E-Mail ID : **************@*****.*** or ***************@*****.***

PASSPORT No.: N9438398

CAREER OBJECTIVE & EXPERIENCE:-

Detail-oriented and self-motivated science graduate with a professional experience in pharmaceutical industry having knowledge in Project Management & Quality Domain.

EXPERIENCE:-

Present from July 2023 in QA Dept. at Lupin Ltd. Ankleshwar, Gujarat

I have 2.2 year in QA Dept. at Macleodspharma ltd. Dahej, Gujarat

I have 1.6 year in QA dept at Glenmark lifesciences Ltd. Dahej, Gujarat

I have 1 year experience in QA dept at Macleodspharma ltd. Vapi, Gujarat

I have 4.3 years experience in QC dept at Biocon Ltd. Bangalore

I have 6 month experience in R&D at Natural remedies ltd. Bangalore

ACADEMICS QUALIFICATIONS:-

2011-2013:- M.Sc Biotechnology, Bangalore university -Bangalore,

T John Group of Institutions, Bangalore, Overall % Marks – 70%

2007-2011:- B.Sc Microbiology, Saurashtra university –Gujarat,

College of Computer Science & IT, Junagadh,, Overall % Marks –61%

2005-2007:- HSC (XII), Gandhinagar board –Gujarat,

Shree Madhyamic School Mandavad, Visavadar, Overall % Marks –53.8%

2004-2005:- SSC (X), Gandhinagar board –Gujarat,

Shree Madhyamic School Mandavad, Visavadar, Overall % Marks –66.30%

ADDITIONAL QUALIFICATION:

CCC Course in DOEACC Society- Delhi on Nov 2008

Certification (PMP® no.: 4062998) by PMI on March 15, 2024

ACADEMIC PROJECT and Publication:-

1.Antifungal and Antibacterial activity of Tinospora cordifolia and Lantana camara medicinal plants extract against pathogenic bacteria & fungi sp.

2.QUALITATIVE PHYTOCHEMICAL SCREENING OF DIFFERENT SOLVENT EXTRACTS OF T. CORDIFOLIA STEM AND L. CAMARA FLOWER research paper Published in (IRJPAS) 2013; 3(5):210-213

Professional Skills:

Handling of Vendor Qualification, Audit, Agreement, Complaint, notifications & Annual Vendor performance and Contract testing lab Qualification, Agreement & Audit.

Handling Quality Risk Management

Analytical method validation & transfer review and approval as per pharmacopeias and preparation and review of Analytical Documentation as per GxP compliance ICH guideline practice.

Handling and participate in Internal Audits and External Audits for the adherence to the GLP compliance.

Handling of Incident/OOS/OOT/Failure Investigations & Its Monthly Trends., non-conformance CAPA, CC, Deviations, market complaint, APQR, and Regulatory quires & its compliance .

Responsible for compliance of instrument Qualification URS/IQ/OQ/PQ, Electronic Record and Data Integrity assessment, Privilege matrix, Monthly audit trail, back-up & restore and their review as per audit requirements (ICH:21CFR and ANX-11)

SOFTWARE HANDLING SKILLS:-

Empower3 CDS, QMS track Wise, EDMS, Caliber LIMS, SAP,GXP,Openlab CDS, Chromeleon CDS and other analytical instrument softwares .

PROJECTSUNDERTAKEN:

1.Stability monitoring program of Biosimilar:

Initiating stability study plan for biologically derived pharmaceutical products based on regulatory requirements.

Planning the stability study schedules for biologically derived pharmaceutical products by coordinating with Quality Control department.

Reviewing the raw data generated from stability sample analysis to ensure compliance to approve procedure and data integrity. Preparation of stability summary reports at each stability study interval.

Active tracking and monitoring for timely analysis of ongoing stability study programs as planned at the start of the study.

Closing the stability study program based on its study report after completion of the entire planned study duration which further establish the shelf life of biologically derived pharmaceutical products.

2.Vendor Qualification of input materials:

Initiating vendor qualification activity for raw and packaging materials used in manufacturing of product derived pharmaceutical products identifying different eligible vendors.

Planning the entire vendor qualification activity by defining the requirements for its qualification as per the approved procedures as well as scheduling of the site audits for the same.

Coordinating with the vendors for the documents submission and further review of the same as well as from concerned technical persons as per the approved procedures and regulatory requirements.

Monitoring the vendor qualification activity for its compliance with the approved procedures as well as with the approved timelines.

Preparation of final closure report and approval certificates & agreement after successful completion of vendor qualification activity before its handover to the operations section for routine procurement during production of biologically derived pharmaceutical products.

3.Implementation of QMS track Wise:

Initiation of Quality Assurance Management System (QAMS) implementation project by obtaining documentary approval for the same from higher management of the organization.

Drafting the schedules and timelines for the entire implementation of QAMS system by identifying the major milestones and agreeing with stakeholders on the timelines.

Providing the classroom as well as web based training to all the stakeholders on handling and usage of QAMS system before its actual implementation at site.

Active tracking and periodic monitoring of the QAMS system implementation status by conducting cross functional meetings. Updating senior management on the achieved milestones against planned schedule and approved acceptance criteria.

Preparation of final closure report on the entire QAMS system implementation activity by capturing the lessons learned during its implementation which can be used as a reference during the implementation of similar kind of system in future.

RESIDENTIAL ADDRESS

#12,Swaminarayan society,OPP to samruddhi residency, bharuch-392011,Gujarat,India

PERMANENT ADDRESS:-

#163, Main Bajar Patodiya Street,

Kothpipariya.Ta: Dhari, Dist: Amreli,Gujarat-365640.

ACHIEVEMENTS:-

Stability Project Management.

Certificate of appreciation in recognition of contribution towards regulatory submission of Perseus program (Pegfilgrastim) & Hercules program (Trastuzumab).

Contribution towards approval of Insulin-glargine in Japan market

QMS track Wise system implementation

Power Bi & Vendor Q-Score module introduced in vendor management activity

ATTENDED:-

Involved in various audits from USFDA, Health Canada, EMA, EUGMP,PMDA, WHO,TGA,CDSCO,ISO Audit and other regulatory and Customer audits .

DECLARATION:-

I hereby declare that the above mentioned information is true to the best of my knowledge. If I will be select for said post, I promise you to do my work very honestly and regularly.

PLACE: Gujarat SARADHARA RAHUL A.

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