Biocon Biologics Limited, a subsidiary of Biocon Limited, is a fully integrated global biosimilars organization. It is leveraging cutting-edge science, innovative tech platforms and advanced research & development capabilities to lower treatment costs while improving healthcare outcomes. It has a strong research pipeline of biosimilar molecules across diabetes, oncology, immunology, and other non-communicable diseases. Six molecules from Biocon Biologics’ portfolio have been taken from lab to market in developed markets like United States, EU, Australia, Canada and Japan. With a team of ~ 4,800 people, Biocon Biologics is committed to transforming healthcare and transforming lives by enabling affordable access to millions of patients’ worldwide.
Vacancy Details
For DP Packing & Medical Device
Roles & Responsibilities:
- Responsible for preparation, review and revision of the batch document s and SOPs
- Responsible for preparation of URS for new equipment and instruments.
- Preparation of the Qualification protocols for the new equipment and Instruments.
- Identification and raising of deviation, change controls and compiling other GMP documents.
- Responsible for implementation and closing of the CAPA related to Facility equipment and process.
- Responsible for taking initiation for improvement in the process and procedure.
- Responsible to ensure QMS is followed in operations.
- Should be responsible for monitoring of the Production activity and output.
- Should have Audit experience (USFDA, MHRA, EMA etc.. )
- Should have experience on Pen Devices, Packing, and handling new projects.
For Asceptic Manufacturing
Job description:
- Acquainted with current Good Manufacturing Practice, pharmacopeia, different regulatory requirements and drug and cosmetic acts.
- Basic knowledge of microbiology, pharmaceutics, pharmaceutical chemistry, Biotechnology, Data Integrity, ALCOA and other related pharmaceutical subjects.
- Ensure quality of drug product at difference stages.
- Ensure data integrity and compliance to quality and regulatory requirements at all times.
- Advanced data analysis; comfort with change, adaptability, and continuous learning; and critical thinking and decision making.
- To coordinate with compliance team and QA-QMS for documents i.e. change controls, CAPA, Deviations, QRA, Technical document, Study Protocols and reports.
- Handling of Internal audits and external audits, and to coordinate for department audits.
- Ensure control on microbial contamination in manufacturing area by effective cleanliness of equipment/area and following aseptic practices.
- Ensuring documents availability for batch activity and its online documentation.
- Following of aseptic techniques, gowning procedures and carry out aseptic area operations with good aseptic area behavior.
- To involve in media filling, qualifications and validations in coordination with cross functional teams.
- Ensure that manufacturing area activities i.e., batch manufacturing, vial washing, filling aseptic area entry / exit, autoclave unloading, CIP, SIP, filtration, filling, lyophilizer loading / unloading are carried out in compliance with the cGMP requirements, SOPs and BMRs.
- Maintain the change parts, spares which are required for all the equipment of aseptic areas.
- Ensuring operation and cleaning of autoclaves, vial washing machine, Depyrogenation tunnel, Filling & sealing, Lyophilizer, Manufacturing vessels, Manufacturing vessels, Filter integrity machine etc. as per respective SOPs. Ensure PMP and qualification of these machines in coordination with validation team and ensure activities are performed as per set validated parameters for the equipment’s.
For Biosimilars Manufacturing
Roles and Responsibilities:
- Upstream Manufacturing (Microbial & Mammalian)
- Downstream Manufacturing (Microbial & Mammalian)
- Process Engineering (USP & DSP)
- MES
Qualification: MSC/BSC/M.Pharm/B.Pharm/BE/B.Tech/M.Tech/Diploma.
Experience: 3 to 15 years
Walk-In Interview Date: 25 September, 2022
Time: 9.30 AM – 12.00 PM
Venue: Hotel Avasa, Survey No. 64, 15, 24, 25 & 26, Hitech City Rd, HUDA Techno Enclave, Sector 1,Hyderabad, Telangana 500081.