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.

- Valuable 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.

📌 Executive / Sr Executive - Quality Assurance ( QMS & DQA)-Biosimilars (Hyderabad)
🏢 MSN Group
📍 Hyderabad