TotipotentSC is a division of MK Alliance, Inc. a USA based company founded in 2007. TotipotentSC is the highly specialized cell biology reagents and equipment product line with the largest stemc ell portfolio in India, we have a registered office in Gurgaon with subsidiary in Chennai and Mumbai. we mainly focus on marketing and manufacturing a complete range of stem cell biology and immunology products to scientists and clinicians. our company also offers consulting in GMP and Good Tissue Practices for public and private institutions. Additionally we have the most significant product range for use in clinical cell processing which meets GMP standards.
Post: Manager - Quality Control
Job Description:
1. Develop, implement, communicate and maintain a quality plan to ensure the Company’s Quality Systems and Policies are in compliance with quality system requirements of Directive 93/42/EEC (EUROPE), US FDA Quality System Regulations specific to Cellular Therapy Devices.
2. Working with purchasing staff to establish quality requirements from external suppliers.
3. Ensuring compliance with national and international standards including ISO13485 and ISO9001:2003.
4. Ensuring tests and procedures are properly understood, carried out and evaluated and that product modifications are investigated if necessary.
5. Ensuring compliance of clean room environment.
6. Writing technical quality management systems reports.
7. Persuading reluctant staff to change their way of working to incorporate quality methods.
8. Manage and maintain the Company’s quality inspection and product release programs for incoming and in-process materials and components, processes and finished goods.
9. Formulate and manage the development and implementation of goals, objectives, policies, procedures and systems pertaining to the QA/QC.
10. Maintaining awareness of the business context and company profitability, including budgetary control issues.
11. Assessing the product specifications of the company and its suppliers, and comparing with customer requirements.
12. Considering the application of environmental and health and safety standards.
13. Agreeing standards and establishing clearly defined quality methods for staff to apply.
14. Setting up and maintaining controls and documentation procedures.
15. Liaising with customers’ auditors and ensuring the execution of corrective action and compliance with customers’ specifications.
16. Monitoring performance by gathering relevant data and producing statistical reports.
17. Organize and manage quality assurance function in close co-operation with the customers and with the Company’s Management team (Member of Management Team).
18. Identifying relevant quality-related training needs and delivering training.
19. Collating and analyzing performance data and charts against defined parameters.
20. Coordinate Corrective Action Preventive Action (CAPA) System within the company's QMS.
Candidate Profile:
1 Master’s Degree in an applied science or engineering field.
2. 5 years prior experience in Quality Control for medical device manufacturer only.
3. Demonstrated experience working with contract manufacturers, suppliers, or distributors.
4. Demonstrated exceptional written and oral communication skills in English.
5. Proficiency in Microsoft Office, Powerpoint, and Project Management Software
6. Passion and alignment with our mission, vision, values & operating principles.
7. Significant experience in quality management systems.
8. Experience in quality system audits.
9. Demonstrates a passion and a responsibility for consumer.
10. Exhibit a passion for the company’s Essence, Global Imperatives, Corporate Direction.
11. Desire to own decisions and take responsibility for outcomes.
12. Willingness to travel when required.
Other Information:
Experience: 2-5 years
Education: B.Tech-Bio-Chemistry/Bio-Technology , B.Sc, M.Sc
Location: Mumbai
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: QC
Compensation: Rupees 3,00,000 - 5,00,000
Candidate may mail their resume at, hr@totipotentsc.com
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