Consultant CQV

We are seeking an experienced CQV Consultant to support commissioning, qualification, and validation activities for pharmaceutical manufacturing facilities in compliance with global regulatory standards. The role involves hands-on execution, documentation, and coordination across engineering, quality, and operations teams.

Responsibilities

• Commissioning

1. Execute and document commissioning activities for process equipment, utilities, and facilities.
2. Support FAT, SAT, and IO testing.
3. Coordinate with vendors, engineering teams, and automation for system readiness.

• Qualification

1. Prepare and execute qualification protocols (DQ, IQ, OQ, PQ).
2. Ensure equipment, utilities, and systems meet URS and regulatory expectations.
3. Perform risk assessments (FMEA, QRM as per ICH Q9).
4. Support cleanroom qualification and HVAC validation.

• Validation

1. Support process validation, cleaning validation, and computerized system validation (CSV).
2. Ensure data integrity principles (ALCOA+) are followed.
3. Prepare and review validation reports and traceability matrices.

• Documentation & Compliance

1. Develop and review URS, SOPs, protocols, and final reports.
2. Ensure compliance with cGMP, FDA, EMA, MHRA, WHO, and ISPE guidelines.
3. Participate in internal audits and regulatory inspections.

Cross-Functional Collaboration

1. Work closely with QA, Engineering, Automation, IT, and Operations teams.
2. Provide CQV expertise during project lifecycle and handover.

Qualifications

• Experience: 8–10 years (flexible based on expertise)
• Education: B.E./B.Tech (Mechanical / Electrical / Instrumentation / Chemical / Automation Engineering)

Required Skills & Competencies

• Technical Skills

1. Strong understanding of pharmaceutical CQV lifecycle.
2. Experience with GMP utilities (HVAC, PW, WFI, Clean Steam).
3. Familiarity with automation systems (PLC, SCADA, DCS).
4. Knowledge of regulatory guidelines (21 CFR Part 11, Annex 11).
5. Exposure to GAMP 5, ISPE Baseline Guides.

• Soft Skills

1. Strong documentation and analytical skills.
2. Excellent communication and stakeholder management.
3. Ability to work in regulated, project-driven environments.