• Gender: Male
• Age: 45
• Designation: Department Head
• Highest Education Level: Graduate - Degree
• Preferred Country: India
• Notice Period: 60  Days
• Preferred Location: Madhya Pradesh, Gujarat
• Work Experience: 19.3 Year(s)

Education

Diploma in Quality Assurance and Quality System 9000/ISO 9001 From Indian Institute of Management and Technology, Chennai.

B.Sc.(PCM) From Vikram University, Ujjain in 2001

12th From M.P. Board, Bhopal in 1998

10th From M.P. Board, Bhopal in 1996

Skill Sets

Experience in the Pharmaceuticals packaging industry ( DMF Grade HDPE bottles and PP CT/CR Closures) for Regulatory Market. Successful track record of handling Quality Assurance Department including Validations, process Improvement, GMP / GLP Monitoring, handling of audits, vendor evaluations, exposure towards ISO, safety and environmental standards., leading cross functional teams to achieve organizational objectives. Effective communicator possessing excellent presentation skills. Motivated to make my career in the field of Pharmaceutical/Process industries. Ready to work in demanding & challenging work environments/organization where I can utilize my educational gains & personal capabilities with matching compensatory package

High Energy level and willing to learn.
Work in team and to work under stress.
Positive attitude and Punctual
A good Team Leader

Work Experience

Head – QA : Since Mar. 2014
Manager – QA/QC : Nov 2010 to Feb 2014
company Profile : ISO 9001-2015 certified company leading manufacturer of DMF Grade HDPE Containers for Regulated Markets, company is engaged in the manufacturing of pharmaceutical Containers meant for packing drugs.
Job Profile:
Responsible for overall quality system preparation, review, implementation and compliance as per current guidelines and practices.
Preparation, review and Co-ordinate for timely regulatory submission of DMF’s and annual updates.
Approval and review of master documents like Batch documents, Specification(RM,PM & FP), STPs and SOPs etc.
To perform internal self-inspection of production, engineering, warehouse and quality control deptt. and ensure CAPA.
Ensure testing as per the US Pharmacopoeia for drug plastic bottles.
Ensure all quality control testing and inspection for incoming, In-process and finished goods.
Ensure working in the lab as per GLP, WHO and US FDA standards
Responsible for Vendor development, Vendor Audit and vendor evaluation.
Preparation of Tracking record for different activities like Validation and Calibration
Responsible for market complaints categorization, investigation, response, CAPA and closure.
Management representative ( MR) for ISO.
Change Control management and Deviation.
Involved various customer agreement and outside laboratory contract.
Product Development and Mould Qualification.
DQ, IQ, OQ and PQ

Key Accomplishments:
Filing and getting DMF number for US FDA DMF and Health Canada DMF for HDPE Bottles
Reduction in Packaging cost and inventory control by Implementing common packing size for all the products.
Improvement in Quality and efficiency of workers by training of Operators, Helpers and Labours.
Achieved Zero level Quality Defect product
Achieved ISO 9001:2008 and then ISO 9001:2015 certification as Management Representative
Revision in Batch Numbering system to reduce the per batch testing cost and documentation.
Successfully setting-up a straw division with extrusion machine to produce PP transparent straws for one the leading MNC.

Asst. Manager – QA/QC
Dec 2005 to Nov 2010
Company Profile: Engaged in the manufacturing of pharmaceutical Container and Closures meant for packing drugs that are to be exported to USA & Canadian Market; clientele includes reputed multinationals like Ranbaxy Labs, Dr. Reddy’s Labs, Lupin Labs, Matrix Labs, Glenmark Pharma, Torrent Pharma, Zydus Cadila Healthcare, Mylan labs, Amneal Pharma and many more
Job Profile :
Promote the concept of quality, the principles of quality Managements and implement quality improvements
Product development & regulatory affairs documentation.
ISO documentation, surveillance audits and follow up.
Prepare Validation Protocols like Area Validations, Equipment validations, Process Validations, Cleaning Validations.
To prepare and execute Qualification Protocols Like DQ, IQ, OQ, PQ.
Decisions for making Batch & Batch Traceability.
Sample preservation of each batch.
Feed back from processing, result & discussion.
To attend and resolve customer complaints regarding quality and processing and training of all new trainees.
Routine Maintenance, calibration and upkeep of analytical instruments and other analytical facilities.
Responsible for Quality control of raw materials, in-process products, finished products, packaging materials.
Test analysis of bottle as per methods specification set by United States Pharmacopeia (USP)
Investigation of OOS results.
Preparation of COAs for batch/ consignment release
Clean Room Validation

Key Accomplishment:
Active assistant to Quality & regulatory Head to get Canadian FDA and ISO 9001.
Lab set up & HDPE product testing ; Installation of instrument & calibration of Stability chamber, Hot Air oven, water bath, pH meter and etc.
Active cooperation with Quality & regulatory Head to get Canadian FDA.

Technical Skills:
Exposure towards ISO-9001:2015, DMF,GMP, setting SOPs .
Understanding of Quality Assurance system, GMP & techniques, materials, products and applications.
Exposure towards manufacturing technology of containers and closures ; i.e. Extrusion Blow Moulding, Injection Blow Moulding and Injection Moulding
Exposure towards all the Utilities used in Polymer processing Unit.

Competencies:
Total Quality management~ Quality assurance, Regulatory affairs, DMF, Documentation, Quality Control, Validations, GMP / GLP Monitoring, External & Internal audits, Vendor Audit & Evaluations, Handling customer audit, Audit Compliance, New Product Developments, Mould Qualification, Trainings & Personal hygiene practices.

Future Goals

Growth