DILIP NAMA :Contact No. : 01795308460/9027283186/8439374834E-Mail ID : nama.dilip AT gmail.com / dilip.nama AT gmail.com
An accomplished professional aiming for challenging assignments in Quality Assurance/ Quality Control with a reputed organization, preferably in the Pharmaceutical industry.SUMMARY :
** A dynamic professional in pharmaceutical formulation with about 9 years of experience in Quality Assurance/ Quality Control with USFDA, EU-GMP, WHO etc. audit experience.
** Experience in domains like quality assurance, inspection, failure analysis, six sigma analysis, root cause analysis and 5S.
** Sound knowledge of QMS, Method validation, computerized system validation, Cleaning validation, Process validation, media fill & QC instruments.
** Expertise in handling of cGMP compliance, GLP section, Validation, Bulk FG, Stability Section, quality related aspects, capital expenditure, budgets, etc.ORGANIZATIONAL EXPERIENCE :Since Nov’14 : Nectar lifesciences Ltd.(Unit VI) Baddi as Deputy manager QA ANVISA, EU-GMP, WHO, ISO, Approved plant, Manufacturing Dry powder injection, oral and tablets and waiting for USFDA approval.Jan'12-Nov’14 : Pfizer, Haridwar as QC Executive Who certified company, Manufacturing Injection, oral and tablet.June'10-Jan'12 : Panacea Biotech Ltd., Baddi as QC Executive
USFDA, TGA, EU, ANVISA Approved Company, Manufacturing Oral, tablet & capsuleOct'09-June'10 : Piramal Healthcare Limited (Currently known as Abbott laboratories ltd.) Baddi as QC Executive
MHRA certified company, Manufacturing Injection, oral, tablet & capsuleNov'06-'Sept’09 : Pacific India, Baghbania as QC Officer
ISO Certified, Manufacturing tablet, capsule & syrup etc.Key Result Areas : Job profile in Nectar life science ltd :
** Handling cGMP compliance team, to ensure data integrity and Quality management system compliance
** Handling market complain, Deviation, Change control OOS (Out of Specification) and OOT (Out of trend)
** Coordination with Regulatory affair to fulfill dossier requirement for different regulatory market and customer
** Vendor audit, internal audit and management review team member.
** Training on cGMP and QMS in plant.
** Ensuring stability study compliance as per different country requirement. Job profile in Pfizer ltd :
** Handled GLP and FG team, to ensure QMS compliance and timely release of finish product and validation product
** Investigation of OOS, OOT market complaint and deviation, ensure implementation of appropriate CAPA and its effectiveness.
** Ensure timely Calibration of instruments.
** Internal audit team member.
** Preparation and ensure Audit compliance.
** Review of QC raw data to ensure data integrity.
** Preparation of QC budget.Job profile in Panacea Biotech ltd :
** Analysis of raw material and finish product and calibration of QC instruments. Job profile in Piramal health care ltd(Abbott laboratories ltd) :
** Analysis of finish product and stability product. Job profile in Pacific India :
** Testing of raw material, finish product etc.ACADEMIC DETAILS :
** M.Sc. Sponsored links :
** M.Sc. (Biotech.)73%
** B.Sc. (Biology)64%TECHNICAL SKILLS :
** Well versed with Trackwise for handling of investigations.
** SAP, MAPS Software and ERP Modules handling experience.Proficient in :
** MS-Office (Word, Excel & PowerPoint) and Internet Applications.
** English & Hindi typing-40 words per minute.
Sound knowledge of cGMP and QC instruments.TRAININGS :
** Attended training sessions in Six Sigma Yellow Belt, Visual Management, 5S, Quality Risk Assessment, GMP & trained the trainer from Pfizer etc.CERTIFICATION :
** Certified Trainer from PFIZER & now from Nectar for training to plant employee.OTHER ACCOLADES :
** Secured 12th rank in Combined Entrance Test (CET) conducted by Kota University in 2004PERSONAL DETAILS :Date of Birth : 30th June 1983Residential Address : H. No. 376/B3 shiv Shakti colony Pinjore (Hariyana)Permanent Address : 2 N 17, Mahaveer Nagar Ext., Kota - PIN Code 324009 RajasthanLanguages Known : English and HindiDATE :PLACE :
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