Biocon Biologics | Specialist
2 months ago
At Biocon Biologics, we are creating a model for the future of healthcare for all. We are a leading company in the biosimilars revolution where patients come first. Our ambition is to impact a billion lives and we do this by fostering a culture of affordable innovation, patient centricity and disruptive thinking. We are a multicultural global company where employees have a purpose and passion to work closely with partners and patients. We have proven end to end expertise in the field of biosimilars, from its development, manufacturing, clinical development, regulatory approvals to commercialization. We have a long-term commitment to bring high quality affordable biosimilars to patients all over the globe.
Responsibilities:
- Represent the Design Quality function on device development project teams and cross functional co-ordination with multiple departments including R&D, Quality Control, Manufacturing and Regulatory Affairs.
- Ensure that device development projects and changes to existing devices are conducted in compliance with the FDA 21CFR Part 820 Quality System Regulation, ISO 13485 Regulations, and other applicable standards like ISO 14971.
- Provide input to design and manufacturing documentation including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting devices can be adequately manufactured and verified.
- Lead or support design activities including design verification, validation, test procedure development, usability engineering, and risk management.
- Set-up of Testing Infrastructure, test benches, jigs and fixtures for testing of mechanical and electro-mechanical Drug Delivery System.
- Plan and execute verification of Prototypes, Pilot batch, feasibility runs for Drug Delivery System.
- Generate or apply statistical methods with appropriate risk-based justification.
- Hands-on experience in Design History File compilation / Technical file documentation.
- Support internal and external inspections/ regulatory audits.
- Promote continuous improvement in design control activities and use of quality tools with design team.
- In-depth knowledge and understanding of 21 CFR Part 820 Quality System Regulation, ISO 13485 Quality Standard, 21 CFR 4 Regulation of Combination Products, 14971 Risk Management Standard, MDD, MDR, IEC/EN 62366 Application of Usability Engineering to Medical Devices, and ANSI HE75 Human Factors Engineering in Design of Medical Devices
Secondary responsibilities:
- Experience interacting with regulatory agencies and notified bodies
- Experience with process improvements, process qualification and validation.
- Experience in complaint investigation, corrective action and preventive action system, statistical methods, quality risk management and Post Market Surveillance.
- Experience: 6 to 9 Years.
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