About the Company
The company founded in the year 2001, from then it is supporting the major innovative companies in development of drug moieties. The company has over 2500 skilled employees with the state of art facility labs and highly qualified scientists. the company has 55 acres of land, and have 5 labs in India. the company has 1.2 million sft chemistry and biological labs. With the sophisticated labs the firm providing a hand to develop high quality and cost effective drugs for the top innovator companies. The company working in the areas but not limited to integrated drug discovery, analytical, formulation developments.
The firm established its operations across the globe in the locations of USA and Netherlands, locally Bangalore, Hyderabad. GVK Bio has the certifications like FDA,EDQM,MHRA,PDMA,WHO-GMP. which certifies that company has a quality in their operations.
About the Job
Department : QA- Validation team
Stream : Biologics/Biosimilars
Location : Unit-2, Doddaballapur in Bengaluru.
1. Associate/Sr. Associate- Experience 3-8 yrs
Qualification : B. Pharma/ M. Pharma
Please find the brief JD as below.
1. To ensure that all the cGMP equipment’s are validated in accordance to standard guidelines.
2. Review and Execution of all Qualification / Validation activities of Equipment’s, Utilities and Areas in Stelis Biopharma Sites
3. Preparation, Execution, Review and Compilation of Performance Qualification and Requalification protocols.
4. Support in preparation and review of SLIA, URS, CLIA, DQ, IQ, OQ and IOQ protocols and reports.
5. Preparation and review of Quality assurance validation departmental procedures in order to assure the established procedures are in line with national and international regulatory requirements.
6. To support cross functional teams in handling Investigations for root cause analysis with regards to Deviations during Validation/ Qualification.
7. Handling of Deviations, change controls and support in closure of action items in order to check the compliance to in house and regulatory guidance’s.
8. Preparation and Execution of Aseptic Process simulations, Process Validation and Cleaning Validation protocols and execution of the protocols.
9. To participate in Qualification/Validation activities executing in the shop floor.
10. Preparation and Review of Quality Risk Assessment Protocols and Reports of QA and Review of user department protocols.
11. Handling of other responsibilities like document issuance (As applicable) assigned by Reporting manager and Head of the department.
Preparation of Project Validation Plan and annual Validation/ Qualification planner
Interested candidates may please share your CVs to [email protected]
For Engineering and projects department:
Stelis Biopharma is hiring for Engineering & Projects DS-Process Equipment team.
Exp-2-8 yrs
Location: Unit-2, Doddaballapura, Bengaluru
JD:
· Attend to preventive & breakdown maintenance Drug substance (DS) process equipment - Microbial & Mammalian: Fermenters, Centrifuges, Homogenizer, HPLC columns, CIP & SIP systems, etc.
· Operation & Maintenance of HVAC, BMS & EMS system.
· Attend to Preventive & Breakdown maintenance of HVAC, BMS system, EMS system, cold rooms and freezers.
· Preparation/Review of SOP, Preventive Maintenance schedule/planner, Documentation etc.
· Knowledge of plant safety & cGMP requirements.
· Coordination with user departments & plan for Preventive/Breakdown maintenance.
· Ensure smooth operation of plant & machinery to avoid breakdowns & production loss.
· Plan for required spare parts inventory & AMC through third party service providers.
· Manpower planning & reporting.
· To conduct periodical energy audits to improve the efficiency of the system & to bring down the operating cost.
· To take care of shift operations and attend to breakdowns.
Prepare/ Review/ Execution of SLIA, URS, DQ, QRM, CLIA, FAT, SAT, IQ, OQ & Support for PQ including EDMS documentation
Interested candidates may please share their Cv to [email protected].