What are the responsibilities and job description for the Commissioning & Qualification Documentation Lead position at Stark Pharma?
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 C Q, 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.