Head - Quality Assurance/Diagnostics - Manufacturing Firm

Head QA_Diagnostics Manufacturing Firm_Mumbai

Job Description:

Looking for a Head-Quality Assurance for day to day quality Management as well as development and implementation of the strategy and improvement initiatives. Institutionalize quality in all products, processes and practices

Client Details :

They are global manufacturer of products that include Native Human Antigens and Polyclonal Antibodies, Diagnostic kits with Rapid Diagnostic Tests, Slide latex kits, and strive to ensure customized quality products that are delivered to IVD manufacturers and suppliers across the world. Instituted in 1989, the company has pioneered in development of Polyclonal Antibodies and Native Human Antigens used in the manufacture of finished reagents in the In Vitro Diagnostic (IVD) Industry. A renowned manufacturer in the IVD industry.

Description :

- Responsible for handling documentation & all other QA Compliance. CDSCO is required.
- Sound knowledge and experience in Regulatory, Registration in foreign countries.
- Responsible for providing expertise w.r.t Regulatory affairs compliance, strategy and logistics.
- Ensure that the best quality practices are implemented in the Organization
- Work closely and liaison with the consultants, internal stakeholder, health authorities and provide inputs on the regulatory strategy
- Mentor a team towards growth by managing their performance, fulfilling their training needs and ensuring compliance to the company policies
- Establish the project goals and priorities.
- Handle all Regulatory Audits, including USFDA etc.
- Guide, Train and Develop Team Members in QA at all locations.
- Implement and ensure that latest technology, systems and processes are being followed.
- Support and advise the management, and the production team in all quality aspects
- Perform and manage internal as well as external audits
- Monitor the quality control from incoming to outgoing goods
- Handle supplier and customer complaints, and manage preventive and corrective actions
- Initiate and manage quality improvement projects
- Keep the quality manual, procedures and work instructions up-to-date in line with customer and legal demands.
- Promote quality best practices within the organization by positively reinforcing the company's quality ethics and encouraging business process excellence.

Profile :

- Candidate should be 12-15 years of Experience in Manufacturing industry with US FDA Approved Company in Quality assurance department.
- Experience in Diagnostic Manufacturing Company will be an added advantage
- Expertise and Experience in handling multiple products and sites.
- Effective Man Management skills
- In depth knowledge regulations of the concerned markets
- Candidate should be good in handling documentation & all other QA Compliance.

Job Offer :

- Opportunity to be work with growth minded organization

To apply online please click the 'Apply' button below. For a confidential discussion about this role please contact Ananya Saxena on +91 (0) 22 4236 3217.

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