Job Summary
This role is for a Quality Documentation & Compliance Specialist responsible for preparing, reviewing, and maintaining GMP documents such as SOPs, investigations, CAPAs, risk assessments, and qualification protocols. The position involves coordinating with QA and cross-functional teams, supporting audits, and ensuring timely closure of quality notifications, CAPAs, and change controls in SAP. You will contribute to regulatory readiness by maintaining accurate documentation, coordinating audit responses, and ensuring compliance with cGMP standards. The role emphasizes training coordination, safety and ESG participation, and fostering a culture of compliance and continuous improvement.
Roles & Responsibilities
. You will be responsible for preparing, reviewing, and updating GMP documents (SOPs, investigations, CAPAs, risk assessments, URS, qualifications).
. You will be responsible for coordinating with QA for receipt of documents and with CFTs for review and approval of master documents.
. You will be responsible for conducting regular audits to ensure documentation is current and compliant with cGMP standards.
. You will be responsible for coordinating audit responses and ensuring timely closure of quality notifications, CAPAs, and change controls in SAP.
. You will be responsible for performing incident and OOS/OOT investigations, identifying root causes, and preparing CAPAs with effectiveness checks.
. You will be responsible for coordinating training within the department, ensuring on-time completion of SOP trainings.
. You will be responsible for maintaining safety standards, participating in ESG initiatives, and adhering to compliance policies.
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You will be responsible for ensuring all quality-related documents are properly controlled, updated, and accessible for regulatory inspections.

Educational qualification: Graduation in Pharmacy, Post Graduation in Pharmacy, Science Biotechnology or related field is preferred
Certifications in Pharmaceutical In-Process Quality Assurance (IPQA), CDSCO Compliance, Pharmaceutical Quality Auditor or equivalent is preferred.
Minimum work experience:
10+ years of experience
Skills & attributes &Critical; exposures
Functional Skills
. Audit Planning
. Change Control
. Incident Reporting
. Pharmaceutical Manufacturing
. Quality Management
. Regulatory Compliance
. Risk Management
. Technical Documentation
Resident Skills
. Current Good Manufacturing Practices (cGMPS)
. Continuous Improvement Process
. Digital Literacy
. Good Documentation Practices
. Lean Methodologies
Behavioural Skills
. Detail-oriented with robust compliance and regulatory alignment mindset
. Collaborative across QA, production, and cross-functional teams
. Continuous improvement orientation with problem-solving and innovation
Critical exposures
. Experience in managing automated QMS Softwares for manufacturing is desired.
. Experience in conducting internal inspections, managing non-conformance including CAPA (Corrective and Preventive Actions), and handling and archiving quality documents is desired.
. Exposure to market complaint handling, deviation management, and impact assessment for compliance is preferred.
. Exposure to quality improvement initiatives and ensuring alignment with manufacturing quality standards and best practices is preferred.

📌 Team Leader Manufacturing - QMS (Hyderabad)
🏢 Monster - xshruthix
📍 Hyderabad