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 Velidation 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

- Qualification of Process and equipment for manufacturing of world class product in India.
- Participation and coordinating, Regulatory and Corporate Audits & ISO 13485 cert6ifications
- Statistical process control for the process monitoring and performance –cPK, Ppk, Z/Bar and
R/Char, P-Charting etc.
- Conduct inter- Rater studies for Shop floor and Quality Associate to develop skill competence
- Knowledge 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 Standers, ISO 2859,C=0,
Variable Sampling Plan and maintain records of DHR (Device History Record)
- Maintain and improves products quality by completing product, Company, System,
Compliance, and surveillance audits; investigating customers 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 specification
- Preparation of quality documentation and report by collecting, analyzing and summarizing
information and trends including failed processes, corrective action, 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 deviation and change control documents
- Handling of market Complaints

Previous Organization:

Company: SUN PHARMA Sikkim

Designation: OFFICER-2 Quality Assurance

Duration: June-2011 to Sep-2011

Job Responsibilities:

- Issuance and retrieval of BMR, BPR and allotment of Batch numbers.

- Performance line clearance at each stage like dispensing, Granulation, Compression. Coating
and Packing.
- Review and compilation of Deviation and Change Controls.
- Stage and Review of BMR and BPR to facilitate timely release of batches.
Previous Organization:

Company: Ankur Drugs and Pharma Ltd. Unit- II Baddi (HP)

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.

- Performance line clearance at each stage like dispensing, Granulation, Compression. Coating
and Packing.
- Performing IPQA activity at shop floor in Table (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 entire 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 form WIPU Geneva
- Certificate course in DRA from B.R. Nahata College of Pharmace, Mandsaur

Personal Ability

- 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