C&Q Documentation SME

i-Pharm GxP; Lebanon (IN); On-site; USD 110,000 - 140,000; Full time

Job summary

i-Pharm GxP seeks an experienced C&Q Documentation SME to support a major pharmaceutical project through C&Q and into operational readiness. The role will lead the review and approval of GMP documentation on behalf of the Owner, coordinating with Quality, Engineering, Vendors and Contractors to ensure timely, high-quality deliverables.

The position focuses on GMP/C&Q documentation for isolators, downflow booths, fume hoods and related utilities, with on-site presence required one week per month.

Qualifications

• Strong GMP pharma/biotech experience.
• Experience reviewing and approving GMP/C&Q documentation.
• Background in manufacturing, process engineering, analytical operations or related discipline.
• Knowledge of isolators, downflow booths and fume hoods.

Responsibilities

• Review and approve GMP/C&Q documentation.
• Coordinate reviews, comments and approvals to completion.
• Interact with Quality, Engineering, Vendors and Contractors.
• Identify and mitigate documentation risks and delays.

Skills

GMP experience

GMP/C&Q docs

Manufacturing background

Isolators knowledge

Downflow booths

Fume hoods

Stakeholder management

Cross-functional coordination

Job description

Site Requirement: 1 week on site per month

Rate: Competitive W2 rate + expenses

We are seeking an experienced C&Q Documentation SME to support a major pharmaceutical project through C&Q and into operational readiness.

The role will lead the review and approval of GMP documentation on behalf of the Owner, working closely with Quality, Engineering, Design, Vendors and Contractors to ensure documentation is completed on time and to the required standards.

Key Responsibilities

• Review and approve GMP / C&Q documentation.
• Manage reviews, comments and approvals through to completion.
• Focus on isolators, downflow booths, fume hoods and temperature monitoring, as well as Utilities and AGVs.
• Act as the Owner’s Representative, coordinating with Quality, Engineering, Vendors and Contractors.
• Identify and resolve documentation risks and delays.
• Support the warehouse through post-TC to pre-TCCC.

Key Requirements

• Strong GMP pharmaceutical / biotech experience.
• Experience reviewing and approving GMP / C&Q documentation.
• Background in manufacturing, process engineering, analytical operations or a related discipline.
• Strong knowledge of relevant pharmaceutical equipment, particularly isolators, downflow booths and fume hoods.
• Excellent communication and stakeholder-management skills.
• Comfortable working across multiple technical and project teams and driving activities to completion.