DP Compliance

2 weeks ago

Bangalore, India Biocon Biologics Full time

About the Company

Biocon Biologics Limited, a subsidiary of Biocon Limited, is a fully integrated global biosimilars organization. It is leveraging cutting-edge science, innovative tech platforms and advanced research & development capabilities to lower treatment costs while improving healthcare outcomes. It has a strong research pipeline of biosimilar molecules across diabetes, oncology, immunology, and other non-communicable diseases. Six molecules from Biocon Biologics portfolio have been taken from lab to market in developed markets like United States, EU, Australia, Canada and Japan. With a team of ~ 4,800 people, Biocon Biologics is committed to transforming healthcare and transforming lives by enabling affordable access to millions of patients worldwide.

Education : Master's degree

Experience : 4-5 Years

Role & responsibilities

Primary Responsibilities

1. Physical/ CCTV monitoring & review of Aseptic practices during Batch manufacturing (Filling machine assembling/ Filling activity/ Handling of aseptic interventions/ Lyophilizer loading / Handling of product contact container & closures/ Environmental monitoring & cleaning of filling machine).

2. Monitoring of Aseptic area cleaning by operators.

3. Monitoring and review critical parameters of the processes of the sterile products.

4. Participate in regulatory audits and ensure audit compliance.

5. Verification of aseptic area activity logbook & entry/exit and ensure its compliance.

6. Identify gaps as per current regulatory requirements and support for implementation of

appropriate corrective actions.

7. Training of the Aseptic operators in Aseptic Practices, Aseptic behavior and Good Documentation Practices on a continuous basis.

8. Perform investigations for deviations related to Aseptic area Practices / Aseptic handling Procedures and close the deviations as per the timelines.

9. Preparation & review of SOP pertaining to Aseptic areas.

10. Appraise the manufacturing operators at regular intervals with latest changes in regulatory requirements

Secondary Responsibilities

1. Handling of OOS and OOL Investigation related to Environmental excursions and ensure closure of report on time and before batch release as applicable (report preparation, report review and closure).

2. Initiation of CAPA related to OOS and OOL for Environmental excursions and ensure its closure.

3. Keeping online tracking sheet for OOS/OOL.

4. Training of manufacturing personnel on relevant SOPs.

5. Ensuring audit Compliance for Fill Finish Production.

6.Risk assessment handlings (1400-Quality-QA30343).

7. Review of JOS, TTDs and other technical documents and coordinating with R& D.

8. Any other assignment assigned by Head of Department

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