Urgent Search Senior Calibration

3 weeks ago

Kolkata, India Tek Support Full time

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.

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