Equipment Validation

3 days ago

Kolkata, India Tek Support Full time

Job Title: Trainer – Equipment Validation

Experience: 10+ years

Location: Remote

Position Overview:

We are seeking an experienced Equipment Validation Trainer to deliver comprehensive training programs on equipment qualification and validation processes in regulated industries. The ideal candidate will have deep expertise in IQ/OQ/PQ execution, equipment lifecycle management, and regulatory compliance, with proven ability to train cross-functional teams in pharma, biotech, and medical device environments.

Key Responsibilities:

- Design and deliver training modules on equipment validation and qualification (IQ, OQ, PQ).
- Train participants on URS/DQ preparation, risk-based approaches, and validation planning.
- Provide guidance on protocol and report writing, ensuring alignment with cGMP, FDA, and EMA requirements.
- Deliver training on calibration integration, traceability, and maintaining equipment accuracy.
- Educate teams on deviation handling, CAPA management, and change control processes.
- Coach participants on cGMP compliance and industry best practices in equipment lifecycle management.
- Conduct workshops on validation documentation, audit readiness, and regulatory inspections.
- Provide practical, case-based training using examples from the medical device, pharma, and biotech industries.

Required Skills & Expertise:

- Strong knowledge of IQ/OQ/PQ execution and equipment qualification.
- Hands-on experience with URS, DQ, validation planning, and execution.
- Proficiency in protocol/report preparation and documentation practices.
- Familiarity with calibration systems and integration with equipment validation.
- In-depth knowledge of cGMP, FDA, EMA, and ICH regulatory expectations.
- Experience in deviation management, CAPA, and audit compliance.
- Excellent training, presentation, and communication skills.

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