High profile Job as Sr. Manager / AGM / GM – Quality Assurance by Nextus Sol

NEXTUS SOLUTIONS is a professionally managed organization engaged in offering highly acclaimed consulting, Training and Placement. With our in- depth expertise and rich experience in the field of domestic as well as international level, we have been serving aspiring candidatesand organizations in the most professional way. We have excellent support of varied resources for meeting the needs of the clients and candidates as per their exact requirements.

Post: Sr. Manager / AGM / GM – Quality Assurance @ Khatraj (Plant)

Job Description:
· Manage and oversee the daily operations of quality assurance.
· Foster and maintain awareness and understanding of quality/regulatory compliance requirements across the organization and create a culture of quality in the company.
· Create and maintain Quality Systems that are in compliance with various quality standards and regulations that mainly include FDA Regulations, various applicable acts, ISO standards, European Medical Device Directive i.e. CE, QMS, and other applicable regulations.
· Maintain CAPA and complaint handling systems, ensuring timely reporting, adequate root cause investigations and compliance to scheduling and completion of resulting action items.
· Create immediate as well as long-term quality plans in line with the organizational requirements and business plans.
· Communicate and establish strategic vision for the Quality Assurance department in the company.
· Monitor, coach and mentor the team.
· Provide recommendations and solutions regarding problems related to quality aspects across organization and cross functional linkages for quality.
· Driving constant quality improvement across organization through various quality systems and practices.
· Represent company during client visits, audits and regulatory agency inspections.
· Analyze inspection findings to determine significance of issues and formulate action plans necessary for quality improvement.

Key Skills / Requirements:
Ø Excellent oral and written communication skills
Ø Strong people skills to maintain and develop strong working relationships across functions.
Ø Ability to manage multiple tasks and priorities effectively.
Ø Knowledge and experience of managing statutory & regulatory compliance related to product, quality and system.
Ø At least 5 years of quality assurance experience in medical device manufacturing environment.

Candidate Profile:
At least 5 years of quality assurance experience in medical device manufacturing environment.
Experience: 15 to 20 years overall and at least 5 years in medical device industry.
Required Education: Bachelor/Master degree in Science, Pharmaceutical, or Engineering discipline
Industry Background: Medical Device Manufacturing Industry

Additional Information:
Experience: 15-20 years
Education: B.Pharm, B.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: QA

End Date: 10th June, 2012

You may call on: 7567566659

Submit your resume at, pharma.nextus@yahoo.com

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