1. SUNIL KUMAR TIWARI (M.PHARM)
S/o Mr. Ram Krishna Tiwari
Address: Vill- Ahiri Firoj pur,
P.O. - Paudhan Rampur
Dist. - Sultanpur (UP)
Pin: - 228171
Mobile: +91-9467390984
E-mail : tiwarisk81@gmail.com,
tiwarisk81@yahoo.co.in
PERSONAL OBJECTIVE PROFILE
I seek Challenging opportunities in a working area where I can fully use my
technical skills and experience for the success and growth of the
organization as well as further development of my capabilities.
SYNOPSIS
5 years and 9 months of experience in Quality Assurance with various Indian Pharma
companies and American MNC, manufacturing and exporting Medical Devices and
Healthcare products to US and European markets.
• Registered as a PHARMACIST (Reg. No- 48035) in PCI under the pharmacy
Act 1948.
Keys knowledge areas are as follows:
• Qualified Internal Auditor for ISO 13485:2012
• Currently working on development and transfer of new medical devices to India
location from Europe/US plants.
• Good knowledge of PFMEA, ISO 14971, DFMEA, FDA Quality system
regulations.
• Excellent knowledge on Validation Methodologies including IQ, OQ, PQ, and
Statistical tools.
• Good knowledge of Good Manufacturing Practices (GMP), cGMP and Schedule
M for Qualification of Manufacturing Processes.
• Good knowledge of writing protocols and reports.
• Use of Statistical software like STATISTICA.
PROFESSIONAL EXPOSURE
Organization: Hollister Medical India Pvt Ltd, Bawal, Haryana
Designation : Sr. Quality Inspector
Company Profile A 100% Export Oriented Manufacturing Plant of
Hollister Incorporated, USA for manufacturing of Sterile
Urinary Catheters and Other Medical Products;
Approval from US FDA; CDSCO/State FDA, India; and
ISO 13485:2003 certification. Hollister Incorporated is
leading world-wide Manufacturer and Supplier of
Continence and Ostomy Care Medical Products
JOB PROFILE
• Internal Auditor for ISO-13485:2003 and EN ISO-13485:2012.

2. • Qualification of Processes and Equipment for Manufacturing of World class
products in India
• Participation and Coordinating Regulatory and Corporate audits and ISO
13485 Certifications
• Statistical Process Controls for the Process Monitoring and Performance- cPK,
Ppk, X-Bar & R-chart, P-charting etc.
• Conduct Inter-rater studies for Shop Floor and Quality Associates to develop
Skill and Competence
• Knowledge of handling of Optical Vision instruments i.e. OGP (Optical Vision
System), Vertex, Peregrine, Burst Tester etc. Training and developing other
members for Documentation and instrument handling.
• Involved in CWR (Change Work Request) Projects, bring out innovative ideas
to improve the process activities.
• Knowledge of sampling plan and proceed testing as per Military Standards,
ISO 2859,C=0,Variable Sampling Plan and maintain records of DHR(Device
History Record)
• Maintains and improves product quality by completing product, company,
system, compliance, and surveillance audits; investigating customer
complaints; collaborating with other members of management to develop new
product and engineering designs, and manufacturing and training methods.
• Development of SOP in compliance with cGMP and in house specifications
• Preparation of quality documentation and reports by collecting, analyzing and
summarizing information and trends including failed processes, corrective
actions, and re-validations.
• Keen learner of trend analysis for process controls and developing of
automated tools for process monitoring
Previous Organization:
Company : Parenteral Drugs India Ltd. Baddi, HP
Designation : QA Chemist
Duration : Feb-2012 to Aug- 2012
Job Responsibilities:
• Issuance and retrieval of BMR & BPR
• Preparation of Protocols and Reports
• Stereo control i.e. receiving, issuance and destruction
• Review of BMR & BPR and Release of Batches in SAP
• Review of deviation and change control documents
• Handling of Market Complaints
Previous Organization:
Company : SUN PHARMA Sikkim
Designation : OFFICER-2 Quality Assurance
Duration : Jun-2011 to Sep- 2011
Job Responsibilities:
• Issuance and retrieval of BMR, BPR and allotment of Batch numbers.
• Performing line clearance at each stage like dispensing, granulation,
compression, coating and packing.
• Review and compilation of Deviations and Change Controls.
• Stage wise review of BMR and BPR to facilitate timely release of batches.
Previous Organization:

3. Company : Ankur Drugs and Pharma Ltd. Unit- II Baddi (H.P.)
Designation : Officer Quality Assurance (IPQA solid Oral)
Duration : Oct- 2010 to May- 2011
Job Responsibilities:
• Issuance and retrieval of BMR, BPR and allotment of Batch numbers.
• Performing line clearance at each stage like dispensing, granulation,
compression, coating and packing.
• Performing IPQA activity at shop floor in Tablet (GB and Effervescent Tabs.)
& capsules Section.
• Sampling as per sampling plan at various In- process stages.
• Review audit logbooks and review other shop floor records.
• During manufacturing process, reviews all manufacturing record to assure that
in process checks and entries are compliance with specification and regulation.
Investigates and notifies appropriate supervisor of manufacturing
documentation verification which could compromise product quality.
ACADEMIC PROFILE
• M. Pharm in PHARMACOGNOSY with 69% in 2010 from B. R. Nahata
College of Pharmacy, Mandsaur (M.P.), A SIRO Recognized by DSIR, GOI.
• B.Pharm with 62.9% in 2008, from Agra Public Inst. Of Tech. & Computer
Education Agra (UPTU)
• Certificate Course in Intellectual Property Rights from WIPO Geneva.
• Certificate Course in DRA from B. R. Nahata College of Pharmacy, Mandsaur (M.P.)
PERSONNELABILITIES
• Initiator, keen learner, proactive and good analytical skills
• Excellent verbal and written communication skills
• Optimistic and Positive Approach
DECLARATION
I hereby declare that all the details mentioned above are true and fits best to my
knowledge.
Sunil Kumar Tiwari