Senior Associate - Dispatch & Solvent Recovery (Drug Substance)

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.

https://www.bioconbiologics.com

Roles and Responsibilities

1.Prepare, review and maintain GMP documentation include but not limit to batch

records, protocols, reports, risk assessment, impact assessment, Standard Operating

Procedures and Equipment Operating Procedures.

2. Ensure accuracy, completeness, and compliance of all documentation with applicable

GMP requirements.

3. Prepare investigation reports and implement appropriate corrective and preventive

actions (CAPA).

4. Support facility expansion projects and equipment installation activities.

5. Review qualification protocols and reports to ensure compliance with GMP

requirements.

6. Ensure compliance with current Good Manufacturing Practices (cGMP), regulatory

requirements, and company quality standards.

7. Follow Environmental Health and Safety (EHS) policies and procedures at all times.

8. Support internal and external audits, inspections, and compliance initiatives.

9. Update and maintain Batch Manufacturing Records and other GMP documentation in

accordance with ALCOA++ principles.

10. Adherence to Standard Operating Procedures, Operational Control Procedures.

Required Skills & Competencies

• Bachelor's degree in chemical engineering, Chemistry, Biochemistry or equivalent field.
• 3 - 5 years of hands-on experience in biopharmaceutical or pharmaceutical Drug Substance manufacturing or related process operations.