Associate Director | Biocon Biologicals

Biocon Limited is a globally recognized, innovation-led organization that is enabling access to high quality, advanced therapies for diseases that are chronic, where medical needs are largely unmet and treatment costs are high.

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We are driven by the belief that the pharmaceutical industry has a humanitarian responsibility to provide essential drugs to patients who are in need and to do so with the power of innovation. In line with this belief, Biocon has developed and commercialized a differentiated portfolio of novel biologics, biosimilars, and complex small molecule APIs in India and several key global markets, as well as, generic formulations in the U.S. and Europe. We are a leading global player for biosimilars and APIs for statins, immunosuppressants, and other specialty molecules, with customers in over 120 countries.

We have built an employee-friendly environment for our gender-diverse workforce that is comparable to the best in the world. This has been validated once again by our position among the Top 20 Best Employers in the Biotech Industry as ranked by the prestigious Science magazine. We have been recognized for being a socially responsible organization with loyal employees who are providing global leadership in innovation.

Position: Associate Director

Location: Bangalore, Chennai, India

Job Description:

Roles and Responsibilities

Role Summary

Lead the quality assurance functions for SNTI in Bangalore, and Chennai.

Key Responsibilities

1. Implement and maintain quality systems to support Research and  Development activities, including R&D, clinical, non-clinical, bioanalytical studies, and pharmacovigilance activities

2. Prepare and implement SOPs required for quality assurance processes at Research and Development

3. Preparation and review of quality system documents (e.g. quality manual, master file, etc.)

4. Train RQA and RND personnel

5. Control of quality system documents and records.

6. Perform audits of vendors, CROs, contract testing labs, etc..

7. Perform quality system audits

8. Report audit findings

9. Maintain records of audits

Educational Qualifications

15. Review of document(s) / records(s) (not limited to the following)

a. Procedures (as applicable)

b. Method development reports

c. Method validation protocols and reports

d. Sample Analysis Protocols and reports

e. Study-related raw data

f. Equipment qualification, validation, and calibration

g. Personnel training

h. Reference material, standards, critical reagents, and sample traceability

16. Approve procedure documents, protocols, reports, equipment qualifications, etc.

17. Any other responsibility assigned in relation to the implementation and maintenance of quality system processes.

Qualification: UG or PG with science and pharma studies with 14 plus work experience 

Experience: Minimum 14 Years

Salary: Negotiable

Contact Details:],, 

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