1. Pradeep Kumar Tiwari
tiwaripk86@gmail.com / pradeep_mpcp@yahoo.co.in
Phone: 8570902274 / 7206565112
Add. -Sec-4 Rewari Haryana
Summary:
• Preparation of S.O.P, Qualification protocol (URS, DQ, IQ, OQ, PQ) Validation Master Plan,
Site Master File and Quality Manual as per regulatory requirement.
• Participate in continual improvement projects for quality systems
• Ensure to maintain Quality Management System and Documentation control.
• Perform validation and verification run.
• DOE (Design of experiment),FMEA, Risk analysis ,SPC (statistical process
control) ,MSA(Measurement System Analysis)
• Support to handling of Deviations, Change Control, CAPA and audit.
• Good understanding of IPQA activity Sampling Testing Inspection and release of product.
• To review the batch manufacturing record, certificate of analysis (in process, finished product)
and release the batch for sale / supply.
• Preparation and submission of regulatory required documents.
• Worked in Transfer Projects.
• Knowledge of GMP, ISO 13485,ISO 9001, 21 CFR 210, ICH and HTM, ISO 14644, EU
GMP, 5S, 6 Sigma
Competencies:
• Statistical Process Control
• Validation and Qualification:
• Qualification of instrument & Equipment.
• HVAC (Area) Qualification.
• Facility Qualification.
• Water System Validation.
• Process validation protocol preparation & implementation.
• Qualification Autoclave.
• Familiar with Vendor approval procedure.
Computer Proficiency And Technical Skills:
• Operating System-- Windows (XP, Vista, and Windows 7).
• Microsoft Office (Outlook, Word, Excel, Notepad, PowerPoint etc.)
• Very good understanding of SAP Modules, QUMAS, STATISTICA, etc.
Professional Experience:
Hollister Medical India ltd Bawal (H.R) – http://www.hollister.com/ SEP 2012 – Till Date
Company Profile:
Hollister Incorporated is a Global independently owned Medical Device Company that develops,
manufactures and markets health care products on a global basis, servicing over 90 countries.
Hollister has become a global leader supplying products for wound care, continence care, patient
identification, obstetric/newborns and breast-feeding.
Role: Quality Inspector
Responsibilities:
• Working in transfer Projects. Protocol, report preparation and statistical analysis.
• Roving Audit ,Internal Audit, R&R Study, Statistical Process Control, Document
Development ,Process Improvement, DOE,FMEA
• Change Control, NCMR, Process Variance, Training, Verification run.
• Sampling as per ISO 2859, Inspection, Testing, DHR Compilation, Product Release.

2. Innova CapTab. Pvt Ltd Baddi http://innovacaptab.com/ SEP 2011 – SEP 2012
Company Profile:
Manufacturer of Tablet, Capsule, Dry syrup and Dry injections of Cephalosporin drugs for reputed
companies.
Role: QA Officer (Documentation)
Responsibilities:
• Preparation of SOP, Qualification Protocol (DQ, IQ, OQ, PQ), Site Master File, Validation
Master Plan BMR, BPR, Dossier and other techenical Document.
• Document Issuance, Retrieval, Archival and destruction.
Reckitt Benckiser Baddi ( Paras Pharmaceuticals Ltd.)- www.rb.com/in July 2010 - Aug 2011
Company Profile
WHO GMP certified public limited pharmaceutical company. It has pronounced presence in both
domestic and international markets, with exports to more than 45countries throughout the World.
.
Role: IPQA Officer
Responsibilities:
• Line Clearance, Dispensing, Sampling, Control sample, on line Documentation.
• Support in Process Validation, Area Validation.
Professional enhancements and skills:
• Audit exposure W.H.O, GMP, NSAI
• Work in project with R.K Laboratories ( Nov 2009 to July 2010)
• Project transfer training In Hollister Ballina Ireland.
• Leadership / Personal Attributes
• Dedicated, responsible and confident.
• Optimistic and Positive Approach.
• Initiator, keen learner, Proactive and good analytical skill.
• Excellent written, oral, and presentation skills
Education:
• MBA. From Guru Jambeshwar University Distance Education, Hissar.
• B.Pharma. (2005-2009) from Maharana Pratap Collge Of Pharmacy Kanpur ,
Personal Details:
Father Name : Nand Kishor Tiwari
Permanent Address : Chunar Dist. Mirzapur U.P
DOB : 18/04/1986
Passport No : M3514112
Declaration:
• I hereby declare that the above information is true to my knowledge and belief.