What are the responsibilities and job description for the Commissioning and Qualification Documentation Lead - GMP position at SRG?
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:
- 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
Key Responsibilities:
- 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.
Impellam Group and its brands are equal-opportunity employers committed to diversity and inclusion. All qualified applicants will receive consideration without regard to race, color, religion, gender, sexual orientation, pregnancy or maternity, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application, interview process, pre-employment activity, and the performance of crucial job functions.
If you require additional disability considerations, modifications, or adjustments please let us know by contacting HR-InfoImpellamNA@impellam.com or fill out this form to request accommodations.
Salary : $90 - $110