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Senior Calibration & Validation Trainer

Senior Calibration & Validation Trainer

ConfidentialKolkata, India
11 days ago
Job description

Job Title : Calibration & Validation Trainer – Pharma Industry

Location : Remote

Job type : Part-time

Job Summary :

We are seeking an experienced Calibration & Validation Trainer with 10+ years of expertise in pharmaceutical quality systems, equipment calibration, and validation practices . The role involves delivering high-impact training programs to professionals and fresh graduates, focusing on regulatory compliance, instrumentation, validation protocols, and audit readiness . The trainer will act as both a technical instructor and career enabler , ensuring participants gain hands-on knowledge aligned with industry standards (FDA, cGMP, ISO, ICH, GAMP5, 21 CFR Part 11).

Key Responsibilities :

  • Deliver comprehensive training on Calibration techniques (Instruments, Equipment, Standards, Protocols).
  • Provide in-depth knowledge on Pharma Validation (CSV, Process, Cleaning, Equipment, IQ / OQ / PQ).
  • Develop training content covering cGMP, GLP, GAMP5, 21 CFR Part 11, and regulatory guidelines .
  • Guide participants in preparing Validation Deliverables (URS, Risk Assessment, Validation Plans, Reports).
  • Conduct practical workshops on calibration & validation procedures used in pharma manufacturing and QC labs.
  • Mentor candidates on audit readiness, data integrity, and compliance documentation .
  • Provide interview preparation, case studies, and real-time project scenarios for career enablement.
  • Stay updated with evolving regulatory requirements, calibration technologies, and validation trends .
  • Collaborate with stakeholders to design customized training modules (onsite / remote / hybrid).

Required Experience & Skills :

  • 10+ years of proven experience in Calibration & Validation within the Pharma / Healthcare industry .
  • Strong knowledge of QA / QC practices, regulatory frameworks, and equipment qualification .
  • Hands-on experience in instrument calibration, process validation, and computerized system validation (CSV) .
  • Familiarity with ISO 9001, ISO 17025, ICH, USFDA, EMA, WHO guidelines .
  • Excellent instructional, communication, and mentoring skills .
  • Ability to simplify technical concepts for diverse audiences (freshers to experienced professionals).
  • Prior trainer / educator / instructor experience in pharma calibration / validation preferred.
  • Skills Required

    Ich, 21 Cfr Part 11, Iso 9001, regulatory guidelines , Glp, Usfda, Process Validation, data integrity, Iso 17025, Instrument Calibration, Cgmp, computerized system validation

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    Senior Validation • Kolkata, India

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