Qms Lead / QMS Professional / Corporate QA / Quality Manager

QMS Lead / Head

Key responsibilities:

• Lead implementation, maintenance, and continual improvement of the site QMS in alignment with ICH Q10, WHO TRS, and USFDA 21 CFR Parts 210/211/600.
• Ensure continuous inspection readiness for

  WHO-PQ

  ,

  USFDA

  ,

  EMA

  ,

  CDSCO

  , and other regulatory agency audits and Lead preparation of inspection plans, SME readiness, and gap assessments.
• Drive CAPA effectiveness checks and closure within defined timelines
• Develop, implement, and maintain the organization's QMS to ensure compliance with standards like ISO/WHO TRS
• Provide oversight on deviation investigation, OOS/OOT handling aligned with FDA and WHO expectations and ensure changes are adequately risk-assessed using ICH Q9 principles.
• Plan and execute internal GMP audits across manufacturing, QC, warehouse, and utilities.
• Prepare and review

  site

  quality

  KPIs

  : deviations, CAPA performance, complaints, product quality reviews, audit findings.
• Lead monthly/quarterly

  Management

  Review Meetings

  (MRM). Prepare and present regular reports on quality performance criteria.
• Oversee corrective and preventive actions to address issues identified during audits and drive a culture of continuous improvement by facilitating quality projects and initiatives across the organization.
• Ability to lead, motivate, and manage cross-functional teams, and develop staff through coaching and training.
• Strong skills in data analysis, identifying root causes, and developing effective solutions, often using statistical analysis or specialized software (Ample Logics/eLog/LIMS) and excellent written and verbal communication to articulate quality goals, write reports, and interact with at all levels.
• Familiarity with industry-specific tools (e.g., ISO standards, SAP systems, statistical software like Minitab and quality management methodologies).

Required Qualifications:

B. Tech / M. Tech / M.Sc. in Biotechnology, Microbiology, Biochemistry, Life Sciences, or related fields. Bachelor /Master of Pharmacy/ B. Tech Biotech/Pharmaceutical technology

Experience

• 815 years in Pharmaceutical/Biologics/Vaccine manufacturing QA/QMS roles.
• Minimum 3–5 years handling WHO-PQ and USFDA inspection preparedness directly.

Technical Skills:

Strong knowledge of:

• WHO Vaccines GMP requirements
• USFDA 21 CFR 210/211
• USFDA 21 CFR 600 series (Biologics)
• ICH Q7, Q8, Q9, Q10
• Data Integrity (ALCOA+)
• Experience in QMS digital systems (Track Wise/Ample logic/eLOG,)
• Thorough knowledge of sterile manufacturing, aseptic operations, and vaccine-specific processe