ASSOCIATE DIRECTOR

  Pharmacovigilance

Job title: ASSOCIATE DIRECTOR

Company: Biocon

Job description: Role Summary

Lead the quality assurance functions for SNTI at 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 implementation and maintenance of quality system processes.

UG or PG with science and pharma studies with 14 plus work experaince

Expected salary:

Location: Chennai, Tamil Nadu – Bangalore, Karnataka

Job date: Thu, 23 Jun 2022 06:07:58 GMT

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