Date of Birth
Civil Id No.
English, Hindi, Arabic,
Urdu, Gujarati & Punjabi
Flat No. 15, Floor No. 4,
House No. 17502,
Street No. 101,
Block No. 3,
To contribute with all my professional skills towards the growth of the organization, with well-directed hard work and extreme dedication. Thus to create a distinct position in the Pharmaceutical field. TECHNICAL SKILLS
Quality Assurance/Quality Control activity
Preparing & Reviewing the SOP’s pertaining to
QA/Warehouse/Regulatory/Clearance/Purchase departments to ensure GMP/GDP compliance of systems, procedures and techniques.
Preparation and review of the Quality Manual, Quality Agreements, MFR, BMR/BPR, SMF, SSP, PDR and other relevant documents like MOA, COA according to USP, BP, EP & IH.
Reviewing the Temperature mapping protocol/reports of Warehouse/Cold room/Freezer as per EU/USP guidelines.
Preparation, Review & implementation of OQ/PQ of temperature mapping for delivery vehicles and cold chain delivery boxes.
Monitoring and Review of Qualification activities as DQ, IQ, OQ, and PQ of instruments and equipment’s.
Executing the Periodic calibration/validation of equipment’s & instruments in the warehouse and quality activities.
Maintain the quality systems such as Trend Analysis, Change Control, Product Recall, Returned goods, Disposal process of Expired items, Re- processing, QCL sampling, Out of Specification, Out of Calibration, Control of Non-conforming products/CAPA, Product Quality Reviews, Stock adjustments and Risk assessments.
Conduct & Evaluation of the EU-GMP/GDP trainings.
Handling of Quality & Non-quality market/customer complaints and counterfeit products.
Internal/External inspections and Perform Supplier Audits and Distributors Audits.
Ensuring the implementation of SOP’s to ensure GMP/GDP compliance of systems, procedures and techniques.
Sound knowledge of ICH, ISO, GMP, GLP, cGMP, EU-GDP regulatory practices and Operating knowledge of Dynamix, SAP, ORION, EDMS, EQMS, Windows 7/10, Adobe Acrobat and Office 365.
Regulatory Affairs activity
Preparation, Review & compilation of Dossier/DMF for registration in regulated, semi regulated & non-regulated countries. i.e. CTD, eCTD, ACTD, EMEA, MHRA as per the requirement of concerned MOH guidance.
Compiling / Writing & submitting regulatory documents in an efficient and timely manner.
Solving queries of customers related to Regulatory Affairs, DMF, CTD, MFR, etc and facilitate quick response to technical queries from various regulatory agencies.
Presently working as QA-In Process Control Supervisor in Yiaco Medical Company, Kuwait from January 2016 to till date.
2 yrs 9 months as Sr QA Compliance Executive in Kuwait Saudi Pharmaceutical Company (KSPC), Kuwait.
18 months as Sr. RA Executive in BDR Pharmaceuticals International Pvt. Ltd, Vadodara, Gujarat, India.
6 months as Sr. QA Executive in Piramal Healthcare Ltd, Maharashtra, India.
One year as QA Officer in K A Malle Pharmaceuticals Ltd, Gujarat, India.
Team member and part of Successful audits of SGS EU-GDP, WHO-GMP, ISO, HACCP, SQF audit, and various routine principal audits from Sanofi-Aventis, GSK, Boehringer, J&J, Roche, etc. PROFESSIONAL QUALIFICATION
Master of Pharmacy in Pharmaceutical Chemistry, (2009), from ASBASJSM College of Pharmacy, Bela, Ropar (Punjab). Affiliated to Punjab Technical University, Jalandhar, Punjab, India with aggregate 73.38 % with Merit position in University.
Registered Community Pharmacist S. No. 25568 in Rajasthan Pharmacy Council, Jaipur, Rajasthan, India.
Diploma in IPR from WIPO, Geneva, Switzerland.
Diploma in Pharma Management from IPER, Pune, India. SCHOLASTICS
Bachelor of Pharmacy, (2007), from B. N. College of Pharmacy, Udaipur (Rajasthan), Affiliated to Rajasthan University of Health Sciences, Jaipur, Rajasthan, India with aggregate 74.89 % with Silver Medal.
AREA OF INTEREST
Quality Assurance/ Quality Control Compliance/ Drug Regulatory Affairs EXTRAMURAL ENGAGEMENTS
Recipient of Best QA Team member and Certificate of Appreciation for SGS EU-GDP certification in Yiaco for the year 2016.
Recipient of Scholarship from Central Wakf Concil, New Delhi, India.
Secured 92% in National Level Pharmacy Talent Search Examination-2007, organized by Pharma Helpline Society, Jaipur, Rajasthan, India.
Results driven, disciplined and excellent in multi-tasking
Maintaining excellent public/corporate relations with strong oral/written communication skills DECLARATION
I do hereby solemnly affirm that all the statements and information furnished above are true, complete and correct to be the best of my knowledge and belief.