Sr.associate - Ds -qa (ipqa) Job in Stelis Biopharma

Group Company: Stelis Biopharma Private Limited

Designation: Senior Associate (A44)

Office Location: Doddabellapura Bangalore

Years of experience: 4 to 6

Salary Range: INR to

Position description: Description: 6 years of experience in Bioprocess industry preferably in Biologicsmanufacturing (USP and/or DSP, Sterile Fill Finish) and at least 3 to 4 yearsexperience with QA/GMP Compliance in clinical/commercial manufacturing. Includingadequate exposure to Global regulatory health authority inspections.

Primary Responsibilities:

• Maintain data integrity in all Activities at Site and ensure appropriate and adequate traceability
• Preparation, review and implementation of Standard operating procedures, Protocols etc., pertaining to Quality Assurance department, in line with Global GMP compliance regulations and industry prac
• To ensure the Sterility assurance of manufacturing activities.
• To ensure all time readiness for Customer and regulatory audits and inspections. Collaborate shopfloor teams engagements on a day to day basis.
• To ensure the quality compliance of Fill finish manufacturing, Warehouse area activities.
• Participation in all the Qualification activities of Equipment and areas in Fill finish manufacturing areas.
• Should have an experience in Handling of Cell Banks/Seed Banks.
• Shouldhave experience in Fermentation technologies and culture developments
• Should have knowledge on HPLC,GC,TFF,Continuous centrifuge and Single use Bioreactors
• Should have hands on experience on Quality Risk Management.
• To ensure the cGMP compliance in the Fill finish Manufacturing and Fillfinish manufacturing Warehouse areas.
  
• All in process quality assurance activities which are executing in theshop floor.
• Providing Line clearance to the shop floor activities (DS,Warehouse ,) asper the respective records/procedures.
• Monitoring of product dispensing activities, Manufacturing activities, in DS Manufacturing
• Preparation, Review and reports of APS protocols, Process Validations,Cleaning Validation, hold time studies and other general studies.
• Collection and submission of samples for In process, Stability, Hold timestudies, Cleaning validation, Media simulation and process validation batches.
• Review of master batch manufacturing records, for DS Manufacturing activities and Review of crossfunctional documents (Protocols, SOPs, qualification documents)
• Review and Execution of allQualification / Validation activities of Equipment and areas in Fill finishmanufacturing areas, Warehouse, Drug substance manufacturing andEngineering. Provide support for reviewand execution of qualification activities.
• Review of SLIA,URS,CLIA,DQ,IQ,OQ,IOQ,PQand commissioning protocols and reports.
• Preparationand review of Quality assurance departmental procedures IN ORDER to assure theestablished procedures are in line with national and international regulatoryrequirements
• To support cross functional teams in handling Investigations for rootcause analysis with regards to Deviations, OOS, OOL and OOT.
• Handling of Change controls and support in closure of action items INORDER to check the compliance to in house and regulatory guidances.
• Preparation of Aseptic Process simulations, Process Validation andCleaning Validation protocols and execution of the protocols.
• Toparticipate in Qualification/Validation activities executing in the shop floor
• Preparation and Review of Quality Risk Assessment Protocols and Reportsof QA and Review of user department protocols.

Additional Responsibilities:

• Handling of other responsibilities (As applicable) assigned by Reporting manager and Head of the department.
• Identification and implementation of cost saving plans within the boundary of Quality management system.