Associate - Dispatch & Solvent Recovery (Drug Substance)

Biocon; Johor Bahru; On-site; MYR 60,000 - 90,000; Full time

Job summary

Biocon Biologics in Malaysia is seeking a Quality Operations Associate to support qualification and validation activities and maintain Solvent Recovery Plant records.

The role requires ALCOA adherence, cGMP and EHS compliance, data entry into quality records, and timely reporting of non-conformities with CAPA actions. A bachelor’s degree in chemical engineering or related field and 1–3 years’ experience are required.

Qualifications

• 1–3 years of hands-on experience in biopharmaceutical or pharmaceutical Drug Substance manufacturing or related process operations.
• Knowledge of cGMP and EHS compliance.
• Excellent documentation and record-keeping skills.
• Familiarity with SOPs and equipment operating procedures.

Responsibilities

• To prepare and execute qualification/ validation and study activities.
• To perform all activities as per Standard Operating Procedures and Equipment Operating Procedures along with ALCOA principles.
• To prepare and maintain documents or record related to Solvent Recovery Plant operations.
• To perform and monitor all activities related to cGMP and EHS.
• To perform data entry in quality records.
• To comply with pollution control and safety requirements as per the policies of the organisation pertaining to EHS.
• To report all non-conformities and implementation of corrective / preventive actions in specific areas of operation.
• To ensure calibration and preventive maintenance of Solvent Recovery Plant’s Storage Tanks, Equipment and Accessories.
• To ensure calibration of pH sensors.
• To perform in-process product sampling, inspection and storage as per Standard Operating Procedures.
• To schedule preventive maintenance of Solvent Recovery Plant’s Equipment in coordination with Engineering Maintenance and Instrumentation Automation Department.
• Authorized to raise deviation reports, deviation requests, and change controls related to Solvent Recovery Plant.

Education

Bachelor’s degree in chemical engineering, Chemistry, Biochemistry or equivalent field

Tools

ALCOA principles

Job description

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. To prepare and execute qualification/ validation and study activities.
2. To perform all activities as per Standard Operating Procedures and Equipment Operating Procedures along with ALCOA principles.
3. To prepare and maintain documents or record related to Solvent Recovery Plant operations.
4. To perform and monitor all activities related to cGMP and EHS.
5. To perform data entry in quality records.
6. To comply with pollution control and safety requirements as per the policies of the organisation pertaining to EHS.
7. To report all non-conformities and implementation of corrective / preventive actions in specific areas of operation.
8. To ensure calibration and preventive maintenance of Solvent Recovery Plant’s Storage Tanks, Equipment and Accessories.
9. To ensure calibration of pH sensors.
10. To perform in-process product sampling, inspection and storage as per Standard Operating Procedures.
11. To schedule preventive maintenance of Solvent Recovery Plant’s Equipment in coordination with Engineering Maintenance and Instrumentation Automation Department.
12. Authorized to raise deviation reports, deviation requests, and change controls related to Solvent Recovery Plant.

• Bachelor’s degree in chemical engineering, Chemistry, Biochemistry or equivalent field.
• 1 - 3 years of hands-on experience in biopharmaceutical or pharmaceutical Drug Substance manufacturing or related process operations