Executive / Sr Executive - Quality Assurance ( QMS & DQA)-Biosimilars

Role & responsibilities

1. Company: MSN Laboratories
   Location: Pashamylaram, Hyderabad, Telangana
   Department: Quality Assurance QMS & DQA
   Experience: 2–7 Years
   Designation: Executive / Senior Executive
   Job Responsibilities
   Quality Management System (QMS)
   
• Implement and maintain the Quality Management System for biosimilar/biologics operations in compliance with GMP and applicable regulatory requirements.
• Prepare, review, revise, and control SOPs, policies, procedures, formats, protocols, and other controlled documents.
• Manage document control, change control, deviations, CAPA, OOS/OOT, incidents, and quality events.
• Coordinate investigations, perform/assess root-cause analysis, and track CAPA implementation and effectiveness.
• Support risk assessments related to manufacturing, testing, processes, facilities, equipment, and quality systems.
• Monitor QMS metrics and prepare periodic quality reports and management-review inputs.
• Ensure timely closure of quality-system actions and maintain appropriate documentation.
• Support internal audits, self-inspections, supplier audits, and regulatory inspections.
• DQA – Documentation / Data & Quality Assurance
  
• Review and approve batch manufacturing records, batch packaging records, analytical records, protocols, reports, and associated GMP documentation.
• Perform review of executed manufacturing and QC documents for completeness, accuracy, compliance, and data integrity.
• Review analytical and manufacturing documentation against approved procedures and specifications.
• Ensure ALCOA+ data-integrity principles are followed throughout GMP operations.
• Review deviations, investigations, change controls, CAPAs, and other quality events from a documentation and compliance perspective.
• Ensure appropriate traceability and reconciliation of critical GMP records.
• Support review and approval of process validation, cleaning validation, analytical validation, technology-transfer, and qualification documents as applicable.
• Identify documentation gaps and coordinate with concerned departments for timely correction and closure.
• Support preparation of documents and responses for regulatory inspections and customer audits.
• Biosimilars / Biologics Exposure
  
• Good understanding of biosimilar/biologics manufacturing and testing processes.
• Knowledge of upstream/downstream processing, formulation, analytical characterization, QC testing, and stability activities is desirable.
• Understanding of critical quality attributes (CQAs), critical process parameters (CPPs), process controls, and risk-based quality management.
• Exposure to biologics-specific GMP documentation and regulatory expectations is preferred.
• Key Regulatory / Compliance Knowledge
  
• Strong knowledge of GMP, GDP, GLP, Data Integrity, ALCOA+ principles, ICH guidelines, and applicable regulatory requirements.
• Familiarity with regulatory expectations of agencies such as US FDA, EMA, WHO, and other applicable authorities.
• Knowledge of QMS, Quality Risk Management, CAPA, Change Control, Deviation Management, and Inspection Readiness.
• Qualification
  
• M.Sc./M.Tech./M.Pharm./M.Pharm (Biotechnology/Biochemistry/Pharmaceutical Sciences)/B.Pharm or equivalent qualification in Life Sciences.
• 2–7 years of relevant experience in Quality Assurance, QMS, DQA, or GMP documentation.
• Experience in biologics/biosimilars/pharmaceutical manufacturing is preferred.
• Preferred Candidate Profile
  
• Strong experience in GMP documentation and QMS activities.
• Good understanding of DQA/batch-record review and data integrity.
• Strong investigation, problem-solving, and risk-assessment skills.
• Excellent documentation and report-writing abilities.
• Ability to coordinate effectively with Production, QC, R&D, Engineering, Regulatory Affairs, and other functions.
• Experience supporting US FDA/EMA/WHO or customer audits and regulatory inspections will be an advantage.
• Ability to work independently and manage multiple quality-system activities within defined timelines.