What are the responsibilities and job description for the C&Q Documentation Lead position at Novozen Healthcare LLC?
Job Title: C&Q Documentation Lead (Commissioning & Qualification)
Job Summary:
We are looking for a C&Q Documentation Lead to support a large-scale GMP-regulated capital project. This is a highly visible opportunity for a hands-on documentation expert who can take full ownership of deliverables, drive quality, and collaborate effectively across teams and vendors.
Key Responsibilities
- Independently draft and develop C&Q documentation from scratch (protocols, reports, and supporting documents)
- Author and manage change controls (CLIAs) related to commissioning and qualification activities
- Lead technical discussions with external vendors to resolve documentation and execution challenges
- Collaborate with Engineering, Validation, QA, and Operations teams to align on strategy and timelines
- Track documentation progress, identify risks, and implement mitigation plans
- Ensure all deliverables meet GMP standards, site requirements, and quality expectations
Required Experience
- 6 years of experience in C&Q documentation authoring from scratch within a GMP-regulated pharmaceutical industry (Mandatory)
- Strong expertise in change control management (CLIAs)
- Experience with URS development and downstream execution
- Ability to collaborate and negotiate with cross-functional teams and vendors
- Experience supporting large CAPEX projects
- Excellent technical writing, organization, and communication skills
- Ability to manage multiple priorities in a fast-paced environment