Biocon Biologics Limited, a subsidiary of Biocon Limited, is a trailblazer in the global biosimilars market. With a mission to transform healthcare and improve lives, Biocon Biologics develops affordable treatments for non-communicable diseases such as diabetes, oncology, and immunology. The company boasts a cutting-edge research pipeline and has successfully launched six biosimilar molecules in developed markets like the United States, EU, Australia, Canada, and Japan. With a team of over 4,800 professionals, Biocon Biologics is committed to leveraging innovative technologies and advanced R&D to enable affordable healthcare worldwide.
Responsibilities in the Job
As a DP Compliance Specialist, you will play a pivotal role in ensuring the highest standards of compliance in aseptic practices. Key responsibilities include:
- Monitoring physical and CCTV activities for aseptic practices during batch manufacturing processes such as filling machine assembly, product handling, lyophilizer loading, and environmental monitoring.
- Overseeing aseptic area cleaning procedures by operators.
- Verifying and ensuring compliance with aseptic area activity logbooks and entry/exit protocols.
- Participating in regulatory audits and implementing audit compliance measures.
- Identifying and addressing gaps in current regulatory practices, and supporting corrective action plans.
- Conducting regular training for aseptic operators on aseptic practices, behavior, and Good Documentation Practices (GDP).
- Investigating deviations related to aseptic handling and ensuring timely resolution.
- Preparing and reviewing Standard Operating Procedures (SOPs) for aseptic areas.
- Keeping manufacturing operators updated with the latest regulatory changes.
Qualifications
- Education: MSc in Microbiology or Biotechnology.
- Experience: 4–6 years in the pharmaceutical or biologics industry, with expertise in microbiology investigations and aseptic area practices.
Key Skills
- Proficient in microbiology investigations.
- Expertise in aseptic area operations and compliance.
- Familiarity with regulatory audit protocols.
- Strong communication and training capabilities.
- Attention to detail and proficiency in documentation practices.
