Stelis is committed to making biological treatments accessible to patients globally. Our products are targeted against large treatment markets that are currently underserved. Our hybrid operating model combines differentiated bio-similar, novel biologics and authorized manufacture and marketing of in-licensed biologics. With R&D and cGMP manufacturing out of Bangalore, India we aim to bring world-class treatments at affordable costs to patients in Emerging and Developed countries.
Engineering & Maintenance
Qualification and Experience : BE/ Diploma in Electrical.
3-6 Years of relevant Experience
Key Skills : Should have experience in handling Preventive, Breakdown & Maintenance of electrical equipment’s related to Formulation- Filling lines. Isolators, Autoclaves, Packing lines. Pass boxes, LAF & Compounding vessels.
Qualification and Experience : BE/ Diploma in Mechanical.
Key Skills : 3-6 Years of relevant Experience
Should have experience in handling Preventive, Breakdown & Maintenance of Mechanical equipment's related to Formulation- Filling lines. Isolators, Autoclaves, Packing lines, Pass boxes, LAF & Compounding vessels.
Qualification and Experience : BE/ Diploma in Electronics/ Instrumentation.
3-6 Years of relevant Experience
Key Skills : Should have experience in Calibration activity planning, execution and documentation for gauges, sensors, transmitters, master calibrators, conductivity meter, particle counter, TOC etc. Hands on experience on troubleshoot and maintenance PLC, HMI and SCADA programmed by Siemens, Allen Bradley, Mitsubishi etc., ladder logic and software backup.
DS Manufacturing
Qualification and Experience :
Upstream Manufacturing
M.Pharm/ B.Pharm/ B.Sc/ M.Sc/ Any Engineering with 3 - 6 Years of relevant Experience
3-6 Years of relevant Experience
Key Skills : Responsible for Monitoring and operation of Fermenters, Centrifuge, Homogenizer, TFF, Autoclave, filter integrity, etc. Responsible to perform the IQ OQ PQ related to Upstream processing Equipment in Drug substance facility. Responsible for Preparation of cell bank. Seed development for the manufacturing batch process. Responsible for Preparation of Protocols, SOPs, BMRs, BPRs and other related documents.
Qualification and Experience :
Downstream Manufacturing
Mpharm/ Bpharm/ Bsc/ MSc/ Any Engineering with 3-6 Years of relevant Experience
Key Skills : Responsible for Monitoring and operation of High/Low pressure Chromatography system, TFF, Lyophilizer, Autoclave, Filter integrity, etc. Responsible to perform the IQ OQ PQ related to Downstream processing Equipment in Drug Substance facility. Responsible for Preparation of Protocols, SOPs, BMRs, BPRs and other related documents
DP Manufacturing
Qualification and Experience :
DP Manufacturing (Fill finish). M.pharm/ B.pharm/ B.sc/M.Sc/ Any Engineering with 3-6 Years of relevant Experience.
Key Skills : Responsible for DP facility manufacturing activities like Compounding, Filtration, Filling and lyophilization of the Vial line products Assist the installation and commissioning activities like FAT, SAT etc. of the Filling lines for vials, formulation vessels. Sterilisers, Lyqphilisers, ALUS, Seeing Machine, Isolator etc.
Quality
Qualification and Experience :
QA - Validation - Mpharm/ Bpharm/ Bsc/ MSc/ Any Engineering with 3-6 Years of relevant Experience
Key Skills : Develop, Implement, control, and upgrade validation approach and systems to ensure that GMP Quality Systems are complied with from Project to commercial manufacturing activities of Drug Substance and Drug product at the manufacturing facility. Coordinate and perform all vendor qualification and compliance audits as applicable to Validations.
Qualification and Experience :
IPQA - Mpharm/Bpharm/Bsc/MSc/Any Engineering with 3-6 Years of relevant Experience
Key Skills : To ensure the cGMP compliance in the Fill finish Manufacturing and Fill finish manufacturing Warehouse areas. All in process quality assurance activities which are executing in the shop floor. Providing Line clearance to the shop floor activities (FFM, Warehouse , Labeling and Packing, and distribution Warehouse) as per the respective records/procedures.
IT
Qualification and Experience : Any Engineering graduate with 3-6 Years of relevant Experience
Key Skills : Maintain 21 CFR part 11 Compliance in all system and process. Support CSV activities related to IT. Implement the data integrity and security measures as per the IT Guidelines. Ensuring regular data backup as per the SOP.
Note: Above all requirements for Associate/ Sr. Associate Position, and Candidates preferred from Injectable - Drug Product /Drug Substance Background.
Required Documents : Resume, Latest Salary break-up letter & 3 Pay Slips; 1 Passport Size Photo, ID Proof, Highest Educational Certificates and Mark sheets.
Job Location : Doddaballapur ( Bangalore) Cab Facility available from Yelahanka.
Walk in Interview
Date : Saturday 19th October, 2019
Time : 09:00 Am to 12:30 pm
Venue
Stelis Biopharma, Plot No. 293, Bommasandra, Jigani Link Road, Jigani Industrial Area, Anekal Taluk, Bengaluru - 560105
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