Assurance Manager Quality
Resume:
Curriculum Vitae: Sarvesh Mishra
From: Date:
Sarvesh Mishra
To,
General Manager,
Human Resource,
Subject: Application for the suitable post.
Dear Sir/Madam,
I Sarvesh Mishra worked as Manager in Quality Assurance department at Avery Pharmaceuticals Pvt. Ltd. Ahmedabad, Gujarat-India, dedicated for NDDS based Mouth dissolving strips manufacturing unit. Previously work with Oral Solid / Liquid / Ointment dosage forms, Nasal preparation and Soft-gel preparation. I am looking for a job in your esteemed organization, where I can excel myself under expert guidance. So, herewith, I am enclosing my curriculum vitae to give all the necessary details exploring possibilities of employment in your revered organization. I am sure that I would be able to make a significant contribution in your forward looking and expanding organization.
Please consider my candidature for the suitable post in your organization. I assure you to prove myself, if selected & I would therefore be obliged if you give me an opportunity. Thanking you, for your consideration.
Hope for favorable response.
Encl: Curriculum Vitae.
COVER LETTER
Curriculum Vitae: Sarvesh Mishra
CURRICULAM VITAE
SARVESH MISHRA
M. Pharm(P’ceutics) from Bhagwant University
Ajmer (INDIA)
CELL: +917*********
EMAIL: ***************@*****.***
Career Objective
Seeking suitable position in an esteemed organization to contribute my skills and work sincerely and enthusiastically thereby profiting the organization and improving my professional career. Competency Area
Review and preparation of Process Validation reports and protocols.
Handling of the project for site transfer i.e. reviews of project documents, master BMR review etc.
Worked as Auditor for API /Formulation Pharmaceuticals Plants.
Familiar with GxP system software like SAP, Pharmasuit and ERP system.
Handling of QMS activities e.g. manufacturing investigation, root cause analysis using investigation tools, CAPA monitoring and change control review for new / site transfer products. Industrial Exposure (11 Years):
I have worked as Manager Quality Assurance in Avery Pharmaceuticals Pvt. Ltd. Ahmedabad
(Gujarat) India in Quality Assurance Department from 18th JAN. 2021 to till date.
PREVIOUS WORK EXPERIENCE
1) (MAR.2018 to SEP.2020) Renown Pharmaceuticals Pvt. Ltd, Vadodara (Gujarat) India (TGA, NAFDAC & WHO-GMP Approved) in Quality Assurance Department as Manager Quality Assurance.
2) (Dec.2016 to Mar.2018) Hindustan Laboratories Palghar, Mumbai (Maharashtra) India (WHO- GMP Approved) in Quality Assurance Department as Asst. Manager Quality Assurance. 3) (Nov- 2015 to Dec-2016) SAVA HEALTHCARE LIMITED Surendranagar, Gujarat India
(SAUMP, TFDA, KFDA and WHO-GMP Approved) in Quality Assurance Department as Sr. executive.
4) (Mar-2010 to Nov-2015) Khandelwal Laboratories Pvt. Ltd. Rudrapur, Uttarakhand, India
(WHO-GMP Approved) in Quality Assurance Department. Audits Faced
SAUMP-UKRAIN (PIC/S),
TFDA- TANZANIA,
KFDA- KENYA,
WHO-GMP
INDUSTRIAL
INDUSTRIAL EXPOSURE
INDUSTRIAL
INDUSTRIAL
INDUSTRIAL EXPOSURE
MICS/ ACHIEVEMESNT
MICS/ ACHIEVEMESNT
Curriculum Vitae: Sarvesh Mishra
RENOWN PHARMACEUTICALS PVT. LTD. JOB ROLES AND RESPONSIBILITY HINDUSTAN LABORATORIES. JOB ROLES AND RESPONSIBILITY
Handling of shop-floor activity.
Leading and Monitoring of IPQA team (02 Executives, 04 Officers & 07 IPQA Chemist).
To look after the review and compilation of documents necessary for Batch Release.
To coordinate and review the process validation protocols /reports for site transfer and new products.
Review of Hold time protocol / report and tracking of hold time sampling.
Responsible for sampling of submission, validation & regular commercial batches.
Preparation of Annual Product Review.
Job Profile
Responsible for Quality Assurance department.
Implementation of Quality Management System.
Review and approval of Qualification document
Review and approval of calibration and validation document
Monitoring the IPQA activity
Review and Approval of all quality control related documents.
Document control
Approval for batch release
Planning, execution and compliance of audit both internal and external.
To review and Approval of BMR, BPR, MFC, SOP, SMF, VMP, Quality manual and vendor
To review and approval of Qualification document (HVAC, Water system, compressed air validation, Preventive maintenance schedule, Temperature mapping and instrument qualification and validation).
To review of process validation, cleaning validation protocol, Hold time study protocol, and analytical method validation protocol.
To review and approval of Change control, Deviation, Incidence, Method of analysis, Specification, Stability report, Technology transfer and Modification of area.
To review, assessment and Closer of product complaint and product recall.
To ensure of implementation of CAPA.
Training
Batch release
To Participation in Internal audit and external audit and compliance.
To review and approval of OOT / OOS
To review and approval of APQR
To approval for rejection of Raw materials, packaging material and finished products.
To handling all regulatory, FDA and cGMP audits of customer.
To compliance to all the responsibilities of quality assurance department.
To ensure all activity is running according to company sop, protocol and with written procedure.
Review and approval of all manufacturing record and QC record for batch release.
Review and approval of Cleaning Validation protocol.
Review and approval of Process Validation protocol.
Review and approval of hold time protocol.
Review and approval of all validation documents.
Review and approval of Qualification documents.
Investigation and handling of market complaint.
Review and approval of Analyst qualification documents. JOB DESCRIPTIONS
DEMICS/ ACHIEVEMESNT
DEMICS/ ACHIEVEMESNT
Curriculum Vitae: Sarvesh Mishra
Responsible for review of master and documentation of SOPs, BMR and BPR. (Exhibit/Submission & commercial products).
Assist in handling of Quality Management System (Deviation, Change control, Market complaints and Investigation).
Training given to subordinates and operators.
Review and approved the artwork of packing materials.
Quality compliance through internal audit.
Audit compliance.
SAVA HEALTHCARE LIMITED JOB ROLES AND RESPONSIBILITY
Process validation (Preparation of Protocol, Report, review & compilation of data as per regulatory requirement).
To look after the review and compilation of documents necessary for Batch Release.
Audit for vendor’s qualification of Raw materials as well as facility audit.
Responsible for sampling of submission, validation & regular commercial batches.
Responsible for review of master and documentation of SOPs, BMR and BPR. (Exhibit/Submission & commercial products).
Assist in handling of Quality Management System (Deviation, Change control, Market complaints and Investigation).
Assist in formulation & implementation of Quality system as per regulatory and PICS guidelines requirements & Work Instruction for procedure of new product.
Successfully trained teams on standard operating procedure, control shop floor practices & ensured discipline
& safety.
Given Training and Guide as per regulatory requirement and PIC/S guidelines.
Exposure of vendor audits for API as well as Facility.
Review QA, QC and updating of documents.
Batch release by reviewing BMR, BPR.
Handling of Regulatory, External & Internal Audits.
SOP preparation, checking, issuance.
Preparation of Master manufacturing document.
Preparation of Site Master File.
Preparation of Validation Master Plan.
Preparation of Quality Manual.
KHANDELWAL LABORATORIES PVT. LTD. JOB ROLES AND RESPONSIBILITY
Monitoring shop-floor activity.
Performing in-process checks and line clearance of manufacturing and packing areas.
Review of BMR and BPR before dispatch of the product.
Execution of Process Validation.
Dispensing of Material as per BMR and SOP.
Maintenance of cGMP regulations in area.
Preparation of QA SOP’s and its gap analysis.
Preparation of Process validation Protocol.
Preparation and issuance of BMR/BPR.
Training given to subordinates and operator.
Quality compliance through internal audit.
Preparation of RM BOM, BMR and BPR of trial & Validation batches as per requirements lay down in line with GMP requirements.
Preparation of APQR.
Leading and Monitoring of IPQA team (02 Officers & 07 IPQA Chemist). JOB DESCRIPTIONS
Curriculum Vitae: Sarvesh Mishra
Professional Qualification
Achievements
• Approval in Tablets Formulation from Commissioner Food and Drug Authority, Uttarakhand, India. Research Experience
Project done during M. PHARM
Project topic: “Sustain Release Formulation and development of Thiocolchicoside SR 16mg Tablets” from F&D department of Themis Medicare Limited Haridwar, Uttarakhand in year 2010.
Project done during B. PHARM
Project topic: “HIV infection and treatment”
Computer Exposure
MS Office, Photoshop & effective utilization of Internet Competences
Self-starter, able to work independently with minimal supervision
Good communication, networking and writing skills
Able to coordinate and collaborate multiple functional teams across the organization.
Net surfing
Exploring new places.
Reading motivation books.
COURSE YEAR OF COMPLETION UNIVERSITY/BOARD
M. Pharm (Pharmaceutics) 2010
BHAGWANT UNIVERSITY
AJMER
B. Pharm 2008 R.G.T.U BHOPAL
Extra-Curricular Activities:
ACADEMICS AND ACHIEVEMENTS
Curriculum Vitae: Sarvesh Mishra
Gender: Male
Date of Birth: 06th Apr. 1980
Marital Status: Married
Nationality: Indian
Religion: Hindu
Language: English and Hindi.
Hobbies & Interest: Reading motivational books, traveling, playing and listening to music. Address: Present address:
Flat. No. D-301, Prerna Tirth Society, Ahmedabad, Gujarat-382110 Permanent address:
H. No. 701, Sector-14, Pocket-II, Dwarka New-Delhi-75. Declaration
I, Sarvesh Mishra, declare that the above information is true and correct to the best of my knowledge and nothing has been concealed or distorted.
Date:
Place: AHMEDABAD (SARVESH MISHRA)
PERSONAL DETAILS:
NAL DETAILS
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