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11/11 Manoj Kulkarni
Director at Shodh Consulting

Views:1412 Applications:37 Rec. Actions:Recruiter Actions:10

Head - Corporate Quality - Chemical (20-30 yrs)

Thane Job Code: 763385

The corporate Quality Head ensures the Products and Services are meeting with the compliance of company's Quality requirements in addition to meeting with the Customers- and Regulatory requirements for Quality, Reliability and Safety

Education : Graduate / Post Graduate in Chemical Eng. or MSc in Chemistry

Experience : 20+ years- experience in Quality function of Chemical / API /Intermediates manufacturing

- Proficient in ERP operating environment and LIMS

- Proficient with personal computer skills, specifically Microsoft office applications

- Working knowledge in SPC / Six sigma is preferred

Role and Responsibilities :

- Responsible for Development, Implementation and strict adherence to the Quality and review all standards, policies, and procedures of all functions involved with product manufacturing and delivery

- Corporate Quality head is ultimate decision maker over the shipment of products and accepts the responsibility for products being in compliance with Regulatory, Customer specifications and company standards

- Reviews and resolves Quality issues / concerns with Site Quality Managers and others including Manufacturing, vendors and customers and with related functions. Coordinate and assist for vendor development

- Periodically inspects Quality plans, check lists, lab SOPs for conformance to standards and customer requirements

- Schedules and performs quality audits across all the sites and reports the findings to Global Head - Business Excellence and develops Corrective and Preventive measures Receives and reviews all customer complaints with complaint trends and product / process failure analysis and develops CAPA with appropriate teams 

- Prepare reports and documentation required for reviews.

- Lead all site Quality teams and train on customer orientation, Robust Root cause analysis, CAPA, reduce recurring problems through appropriate tools

- Develop and constantly improve, through creative thinking, the quality plans, procedures and testing methods employed during the product launching and commercialization - Lead product quality risk management process and ensure right root causes and mitigation strategies are in place

- Provide expertise in critical quality areas of processes, Chemistry, Packaging, Regulatory and validations

- Identify, develop and implement new quality measurement systems including testing automation and lab wide process improvements - Should be familiar with ISO 9001 -2015, SPC and GDP

- Work with teams in Global Quality organization to drive Quality vision and efficiencies with respect to testing SOPs, quality planning, quality development and execution.

- Drive Zero defects and right first time initiatives across the operations. Troubleshoot Quality issues in the manufacturing and packaging processes and perform CAPAs as necessary

- Training, coaching and mentoring team members of all site quality teams to achieve their potential

- Provides or assists on employee training to ensure Quality compliance with procedures and regulations. Technical and working knowledge of quality assurance processes, tools and techniques

- Good in interpersonal skills, problem solving skills, planning/organization skills, strategy and customer focus

- Assist with development of infrastructure for the new Quality Assurance team including; policy, procedures, reporting, and to track actions for improvements. Establish goals for Quality teams and monitor their performance. Ensure they receive periodic performance feedback as appropriate

- Drives the Quality center of excellence. Responsible for the continued development Quality systems, capability and maintenance of compliance in the Labs.

- A collaborative style that can demonstrate the ability to interact and influence many teams to reach their goals

- Good analytical skills to gather and interpret technical information, and to develop, recommend and implement solutions

- Knowledge of wide range lab equipment's and Lean laboratory concepts. Understand business drivers, quality risks, and tradeoffs with the ability to propose risk mitigation approaches to meet the business need

- Improve delivery of key initiatives through the implementation of a hybrid model of Quality Assurance & Quality Control

- Ability to deal with complex quality analysis

- Comfortable working in an extremely dynamic environment

- A change leader in Quality who is highly flexible and able to quickly adapt to changing priorities

- Strong interpersonal skills with excellent oral and written communication skills

- A strong team-player with a passion to improve the product quality

- Organized and self-motivated

- Strong listening and influencing skills to foster an open, innovative and responsive environment and to drive change

- Promote and support an environment that encourages productivity, continuous improvements, teamwork, and a high level of professionalism

Women-friendly workplace:

Maternity and Paternity Benefits

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