HomeProductionAssistant Manager QMS and Documentation -Biologics | Biocon Ltd | Bengaluru

Assistant Manager QMS and Documentation -Biologics | Biocon Ltd | Bengaluru

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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: Assistant Manager QMS and Documentation -Biologics

Location: Bangalore, Karnataka, India

Job Description:

1. Responsible to ensure cGMP compliance for CAPA management and QMS documents of Biological Drug substance manufacturing at site1.

2. CAPA management:

  • Review, login, approval of CAPA, and sending approval notification to concerned personnel through outlook mail by using the recurrence option.
  • Review and verification of documents for CAPA closure & CAPA effectiveness.
  • Track the CAPA closure and effectively present the CAPA system to management on a periodic basis.

3. Review, approval, and closure of QMS elements (Deviation, OOS, OOT & OOAC) and respective investigation reports.

4. Ensuring appropriate partner/ RA/ Customer communications of the deviation, OOS and OOTs and other documents wherever applicable.

5. Periodic review of QMS elements closure and facilitating board meetings with CFT to ensure effective closure of the same.

6. To participate and manage the regulatory, customer, partner, and internal audits regarding QMS procedure and documents.

7. Handling of the Market complaints, Customer returns, Market query, and Recall.

8. To ensure the completion of trend reports, PQR, and QVR within stipulated timelines.

9. Archival and maintenance of QMS documents.

QualificationAppropriately Qualified

Experience: 6-10 Years

Salary: Negotiable

Contact Details:

Mr. Mukesh Guleria

mukesh.guleria@biocon.com, careers@biocon.com, human.resources@biocon.com

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