Commissioning & Qualification Documentation Lead
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Job Location:
Lebanon, NH - USA
Monthly Salary:
Not Disclosed
Posted on:
4 hours ago
Vacancies:
1 Vacancy
Job Summary
The Commissioning & Qualification (C&Q) Documentation Lead is responsible for developing authoring and managing commissioning and qualification documentation in support of GMP-regulated projects.
Location: Lebanon IN
Contract Duration: 3-5 years
Onsite 4 days/week
Required:
Location: Lebanon IN
Contract Duration: 3-5 years
Onsite 4 days/week
Required:
- Firm understanding of writing documentation from scratch; draft write and develop CLIAs (change controls) for CQ URS experience
- GMP/Pharma manufacturing
- Negotiation with external vendors and internal stakeholders
- Effectively work with other teams
- Capex experience/large projects ability to manage multiple priorities
- Independently draft write and develop commissioning and qualification documentation from initial concept through final approval including protocols reports and supporting records.
- Author and manage CLIAs (change controls) related to commissioning and qualification activities ensuring alignment with site procedures and regulatory expectations.
- Lead negotiations and technical discussions with external vendors to resolve documentation scope and execution-related issues.
