• Gender: Male
• Age: 40
• Designation: General Manager
• Highest Education Level: Diploma
• Preferred Country: India
• Notice Period: 30  Days
• Preferred Location: Tamilnadu
• Work Experience: 20.5 Year(s)

Education

Diploma in Packaging from Indian Institute of Packaging (IIP), in 2018 to 2020
Bachelor of Business Administration (BBA) from Annamalai University in 2016 to 2019
Diploma in Mechanical Engineering from Sri Venkateshwara Polytechnic College, in 2000 to 2003

Skill Sets

MS Office, MS Project, Minitab, Auto Cad & Solid Works

Work Experience

General Manager QA, RA & NPD
From May 2017 - Present
Company profile- Medical Devices & Pharma Primary Packaging

Job profile-
Head medical device, Primary Packaging development and Quality as HOD. (India, USA and China Operations)
Mold and Material source, evaluate & develop suppliers (Domestic & international)
Reviewing Product design, concepts, CAD models, Protocols, Design Verification & Validations, Bio compatibility, Test
method development & Validation, Sterilization & Packaging.
Develop & support Process Validation for manufacturing facilities producing medical devices such as insulin pen, Applicators
and Dosing cards.
Regulatory compliance submission of product to all applicable USFDA, ISO, EU, CANADIAN, China & OTHER Standards.
Qualify vendors based on quality, technical ability, service & cost.
Responsible for the product planning and execution throughout the Product Life-cycle, including: gathering and prioritizing
product and customer requirements, defining the product vision, and working closely with engineering, sales, marketing
and support to ensure revenue and customer satisfaction goals are met.
Responsible for Defining QA strategy, approach and execution in development projects.
Responsible for Leading and directing the QA leadership team.
Providing leadership and technical expertise within Test Automation and Quality Assurance.

Manager - Quality and NPD
From March 2017 to April 2017
Company profile- leader in the field of rigid plastic moulding, catering to an array of industries

Job profile-
Papering and Filling DMF for USA for Packaging materials,
Develop strategies to improve the production process
Eyeing on the objectives to maximize the profitability of the organization
Providing training to individuals who handle the product
Make sure whether the product goes through auditing and testing
Make sure whether all the legal standards are met and review thoroughly the existing policies and standards
Review the organization’s process to ensure whether they align with the current policies
Formulate timely reports and documentation to track progress
Identify the training requirements to meet the quality standards
Develop and monitor corrective measures
Make documentation of internal audits and quality assurance activities
Plan, conduct, and monitor the test, and inspecting the products to ensure its quality
Take a look at customer complaints & Analyze the data to find the areas for improvement

Assistant Manager QA & QC
From Jun 2010 - Feb 2017
Doctor Pack India (P) Ltd
Company profile- Pharma Primary Packaging & Medical Devices Eye Droppers, Nasal Sprays & MDI, DPI and Insulin Pen

Senior Engineer Quality
From Oct 2009 - May 2010
Crestanks Ltd | Kampala, Uganda

Safety Officer & Document Controller
From Jul 2004 - Oct 2009
Rexam Pharma Packaging

Job profile-
Head CQA for India, China & USA Operations. (Total 8 Units)
Lead the new product development (NPD) and design quality activities with the
team, MR for ISO Quality Management System (ISO 13485, ISO 9001, 21CFR
820 and MDD)
Overseeing full range of quality related activities QA, QC & supplier qualification,
incoming inspection, in-process inspection, outgoing inspection and etc.
Oversees and lead key quality systems processes to ensure its effectiveness
which includes Quality Planning, Document Controls, Training, Audits, Change
Controls, Non-conformance CAPA, Manage External Requirement, etc.
Drive the Quality function in overall systems, products and processes to meet
quality and relevant regulatory requirements
Plan and coordinate with Production and other internal departments on
non-conformance product issues
Handling Internal Audit and Customer Audits. Continual improve Design Control
activities
New product development and implementation of new products via development of an overall quality plan, including needed inspection, test, and audit procedures; identification of needed reliability testing; identification, procurement, and
maintenance of needed engineering test equipment; and support of process/product validation.
Develop and administers an inspection, test, and/or audit program to ensure that incoming, in-process, and finished products meet functional specifications and quality standards. Ensures completeness, accuracy, and test-ability of product
requirements (Control plans, MSA, datasheets, inspection instructions, etc.).
Support Quality System of development site
Lead the review, disposition, and corrective action activities associated with discrepant components, materials, sub-assemblies and finished products associated new products.
Evaluate all post launch purposed design changes to determine impact on risk level, verification and/or validation testing. Maintain Risk Management Files for site in compliance with procedures.
Lead continuous improvement activities including contributing to system level procedural requirements/updates as needed.
Provide training, leadership and mentor-ship to teams and junior QEs
Ensure adherence to all legal and statutory compliance's at the unit level
Ensure a harmonious work environment at the unit level
Identify Technological advancements and innovations to adapt them to keep the organization’s competitive edge.
Manage all conversion operations through production and packaging to hand-over for dispatch/ warehousing, in order to deliver finished goods against committed production plan.
Initiate plans and processes which minimize manufacturing costs through effective utilization of manpower, equipment, facilities, materials and capital. Review performance data to measure productivity and goal achievement and to determine areas requiring cost reduction and process improvement.
Ensure that personnel policies, procedures and guidelines are administered within the production team in a consistent and equitable manner.
Establish and communicate performance and behavioral standards and expectations to direct reports by conducting timely performance appraisals and ensuring overall optimal achievement of improvement opportunities.
Developing and implementing measurement systems (KPIs) to improve performance at the manufacturing/shop floor
Innovation and new product development and delivery
Managing team and individual performance through regular/daily/hourly reviews, monitoring processes and ensuring correction/adjustment needs are identified and effected
Health, Safety and Environment management to comply with statutory requirements and in line with the company safety policy.