Lead QMS Compliance Professional

About the Company :

Biocon Biologics is a subsidiary of Biocon Ltd, an innovation led global biopharmaceuticals company. Biocon Biologics is engaged in developing high quality, affordable biosimilars that can expand access to a cutting-edge class of therapies to patients globally. It is uniquely positioned as a fully integrated ‘pure play’ biosimilars organization in the world and aspires to transform patient lives through innovative and inclusive healthcare solutions. The Company has a large portfolio of biosimilars under global clinical development with three of these commercialized in at least one of the developed markets of EU, U.S. and Japan. Biocon Biologics has a product pipeline of 28 molecules, including 11 with Mylan, several with Sandoz and is developing many independently. Biocon Biologics believes that strong partnerships offer enormous opportunities to co-create the future of healthcare, building a patient ecosystem beyond the product, which can transform millions of lives.

Website : https : / / www.Bioconbiologics.Com

Role / Position Title : QMS compliance Team member.

Function : QMS Compliance

POSITION SUMMARY

Role 1 - Manufacturing Compliance (biosimilars compliance)

1)Investigating the microbial excursions for facility, utility and process

2)Preparation of contamination control and strategy document

3)Product quality assessments for the microbial contaminations.

4)Preparation of risk assessment protocols and reports

5)Harmonization of procedures and practices as per CQA guidance

6) Representing manufacturing and coordinating for internal & external inspections / audits

7) Coordinating for the audit responses / assessments and implementation of audit CAPAs

8) Driving continuous improvements related to compliance

9) Investigation of Data Integrity related deviations of manufacturing function

Role 2 - Microbial Investigator (Biosimilars compliance)

1) Ensure the microbial events related to product (Deviations, OOS / OOTs), and microbial water excursion (OOS) investigations are timely conducted, and root cause analysis is identified out and appropriate CAPAs are identified to avoid repeat occurrence.

2) Timely assess the impact due to microbial excursion on the ongoing batches and subsequent batches and propose recommendation to the site.

3) Review of Investigation reports for data furnished for correctness of statements, evidence-based review and ensure no errors in the data and conclusions derived.

4) Involve in management review meetings to present the microbial excursions and status of closures.

5) Provide inputs during trending of microbial related deviations, OOS and propose recommendations.

6) Ensure oversight on microbial related investigations, to ensure consistency of global standards, harmonization, sharing of best practice.

7) Drive continuous improvement in microbial investigations to meet and sustain compliance with internal and external regulatory requirements.

Role 3 - QMS (Biosimilars compliance)

1) Management of change controls (Initiation, review, implementation, follow-up & closure).

2) Management of CAPA (Initiation, implementation, follow-up & closure)

3) Management of QMS deviations & Incidents (Initiation, investigation & closure)

4) Preparation, review & closure of risk assessments pertaining to manufacturing department.

5) Completion of trainings before the execution of activities.

6) Adherence to SOP and good manufacturing & good documentation practices