Quality Analyst Supervisor Job in Ahmedabad at Baxter International

Baxter is hiring for the role of Quality Analyst Supervisor!

About the Company:

Baxter is proud to create a work culture that recognizes the struggle parents face when balancing work obligations and work needs. Baxter is a leader in supporting a work environment where families are supported, and employees can do their best work. We are honored to be recognized as one of The Best Companies for Fathers and Mothers to raise their families.

Responsibilities of the Candidate:

• To ensure continuous review of analytical documents generated during the analysis of QC, Stability, and Microbiology for adequacy and accuracy
• To ensure conformance through review of sample audit trails at the time of batch release for PM, RM In-process, and finished product
• To ensure conformance through review of analytical documents in LIMS and release of raw material and finished product in JDE
• To ensure the correctness of the data through periodic review of audit trails for the systems in the laboratory and manufacturing area
• To ensure the compliance of applicable procedures during analysis as well as 21 CFR part 11 in software and handle the observations through QMS
• To ensure the review of daily and periodic calibrations, method transfer documents, and work orders in Maximo and handle the observations through QMS
• QA oversight on batch charging for stability studies
• To review and ensure that periodic withdrawal of stability samples, and excursions of temperatures from the incubators are carried out
• Review of audit trails of manufacturing, packing equipment (PLC/SCADA systems), and computer systems available in engineering, utilities, and store
• To investigate any Out-of-specifications (OOS) or Non-conformity reports or Laboratory incidents and take corrective and preventive actions (CAPA) if required
• To train team members on current good manufacturing practices (GMP), Good Documentation Practices, and good laboratory practices (GLP)
• To approve and ensure the investigation of all QMS elements and related corrective and preventive action as per the approved procedure
• To approve Document change requests and ensure that Document Change requests are closed as per Standard Operating Procedure
• To support & guide team members in implementing change control, corrective, and preventive actions (CAPA) and check the efficiency of CAPA, give suggestions wherever necessary
• To ensure the implementation of current Good Manufacturing Practices, Good Documentation Practices, and Good Laboratory Practices norms in the Laboratory
• To take suggestions from the QA Head regarding CAPA (Corrective and Preventive Action) as per requirement and ensure its implementation within the stipulated timeframe and efficiency of CAPA
• To review and approve SOP from time to time and suggest and implement changes
• To support the QC doc cell team in resolving specification and MOA queries