Rakesh Rana
Pithoragarh
Summary
Dynamic Quality Assurance professional with extensive experience at Skymap Healthcare Pvt. Ltd., excelling in equipment qualification and process validation. Proven team leader with strong documentation skills, adept at internal audits and risk analysis. Committed to upholding quality standards and enhancing operational efficiency in compliance with WHO-GMP regulations.
Overview
13
13
years of professional experience
Work History
Quality Assurance Sr. Executive
Skymap Healthcare Pvt. Ltd.
Roorkee
07.2018 - Current
- Company Overview: WHO-GMP Certified Company
- Fully acquainted with the instrument calibrations/Validation & preparation of SOPs/Protocol as URS/DQ/IQ/OQ/PQ, Root cause analysis etc.
- To conduct self inspection and or quality audit that regularly appraises the effectiveness and applicability of the Quality Assurance System.
- Periodic review of all Quality function and procedures for appropriateness and validity.
- Handle all activities related projects from DQ, IQ, OQ, and PQ of equipment's.
- Facility Qualification
- Process validation
- Personnel qualification and Preparation of authorized person list
- Hold time study of Equipment's / Products
- Media fill validation
- Equipment Qualification like as Sterilization & Depyrogenating Tunnel, Machine, Autoclave.
- HVAC Validation
- Temperature Mapping.
- Compressed air
- Nitrogen air
- PSG Qualification
- Maintaining calibration records of all instruments.
- Maintaining validation master plan of equipment's.
- Any other responsibility assigned by department head.
- WHO-GMP Certified Company
Validation Section
Pure & Cure Healthcare Pvt. Ltd.
Haridwar
10.2016 - 07.2018
- Company Overview: WHO-GMP, ISO 9001:2008, ISO 14001:2004 Certified Company
- Process validation
- Personnel qualification and Preparation of authorized person list
- Hold time study of Equipments / Products
- Media fill validation
- Equipment Qualification like as Sterilization & Depyrogenating Tunnel, Machine, Autoclave.
- HVAC Validation
- Temperature Mapping.
- Compressed air
- Maintaining calibration records of all instruments.
- Maintaining validation master plan of equipments.
- Any other responsibility assigned by department head.
- WHO-GMP, ISO 9001:2008, ISO 14001:2004 Certified Company
QA Sr. Officer
Rushan Pharma
Dehradun
04.2016 - 10.2016
- Company Overview: WHO-GMP Certified Company
- Personnel qualification and Preparation of authorized person list
- Hold time study of Equipments / Products
- Media fill validation
- Equipment Qualification like as Sterilization & Depyrogenating Tunnel, Machine, Autoclave.
- HVAC Validation
- Temperature Mapping.
- Compressed air
- Maintaining calibration records of all instruments.
- Maintaining validation master plan of equipments.
- Any other responsibility assigned by department head.
- WHO-GMP Certified Company
QA Officer
Psychotropic India Ltd.
Haridwar
02.2015 - 04.2016
- Company Overview: WHO-GMP Certified Company
- HVAC Validation of all area
- Media fill validation
- Equipment validation & calibration of injection production, quality control, utility equipments with proper status labels (i.e. LAF, RLAF, Pass box, Thermometer, Megnahelic Gauge, M/c Sterilization & Depyrogenating Tunnel, Washing Machine, Autoclave.)
- To carry out documentation of all departments, log book, format SOPs.
- Dispensing of Raw material and Packing Material.
- Ensure the cGMP compliances on the soft floor.
- Any other responsibility assigned by department head.
- WHO-GMP Certified Company
QA Officer
COOPER PHARMA Ltd.
Dehradun
07.2012 - 02.2015
- Dispensing of Raw material and Packing Material.
- Monitoring IPQA activities in shop floor.
- Line clearance of area, equipment and process after and before, product change over.
- In-process sampling, sampling of raw material & Packing Material.
- Checking the test parameters during each manufacturing stage of Liquid and Dry injection.
- Ensure the cGMP compliances on the soft floor.
- To carry out Documentation of all departments, log books, formats and SOP.
- Prepare issuance and retrieval of BMR & BPR and Maintaining proper records and to carry out the Annual Product Quality Review Record.
Education
B.PHARMA -
DEV BHOOMI IINSTITUTE OF PHARMACY & RESEARCH INSTITUTE
01.2012
Intermediate -
DAYANAND INTER COLLEGE
01.2008
High school -
DAYANAND INTER COLLEGE
01.2006
Skills
- Team-oriented approach
- Social competence
- Equipment qualification
- Team leadership
- Documentation and reporting
- Software testing techniques
- Quality management systems
- Risk analysis and mitigation
- Internal audits
- Data collection
- Quality standards determination
- Process validation
- Computer skills
Languages
- Hindi
- English
References
If needed, shall be provided
Disclaimer
I hereby declared that all the above information in this resume is true and best of my knowledge.
Expected Ctc
Negotiable
Personal Information
- Current CTC: 6.60 Lac/Annum
- Father's Name: Mr. N. B. Rana
- Notice Period: 01 Month
- Date of Birth: 07/20/90
- Gender: Male
- Nationality: Indian
- Marital Status: Unmarried
Affiliations
Awarded 'Best Performer – QA Validation' (Panacea Biotec, 2023), recognized for exceptional contributions in documentation, validation protocols, and audit readiness, reflecting attention to detail and dedication to quality standards
Certified Yoga & Wellness Practitioner (Beginner Level) pursue mindfulness and holistic wellness practices, supporting a balanced lifestyle and mental well-being alongside a demanding career
Languages
Hindi
First Language
Hindi
Upper Intermediate (B2)
B2
English
Intermediate (B1)
B1
Timeline
Quality Assurance Sr. Executive
Skymap Healthcare Pvt. Ltd.
07.2018 - Current
Validation Section
Pure & Cure Healthcare Pvt. Ltd.
10.2016 - 07.2018
QA Sr. Officer
Rushan Pharma
04.2016 - 10.2016
QA Officer
Psychotropic India Ltd.
02.2015 - 04.2016
QA Officer
COOPER PHARMA Ltd.
07.2012 - 02.2015
B.PHARMA -
DEV BHOOMI IINSTITUTE OF PHARMACY & RESEARCH INSTITUTE
Intermediate -
DAYANAND INTER COLLEGE
High school -
DAYANAND INTER COLLEGE
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