C&Q Document Preparation Support (Drug Product)
On-siteHyderabad, Telangana, India
Job Summary
Senior Associate specializing in Commissioning & Qualification (C&Q) to support the preparation, coordination, and delivery of commissioning and qualification lifecycle documentation for engineering projects and GMP manufacturing systems. Partners with Engineering, Validation, Quality, Manufacturing, Facilities, Automation, and Project teams to develop compliant, inspection-ready documentation that supports commissioning, qualification, and operational readiness activities. Authors qualification protocols, reports, risk assessments, traceability matrices, test scripts, and related C&Q documentation, coordinates technical review cycles, ensures documentation accuracy and version control, and supports audit/inspection readiness. Contributes to continuous improvement initiatives focused on documentation quality, consistency, and efficiency across Drug Substance, Drug Product, Finished Drug Product & Packaging, and Facilities & Utilities as applicable.
Required Qualifications
- Experience in GMP commissioning, qualification, validation, or technical operations
- Experience authoring C&Q lifecycle documentation including qualification protocols and reports
- Familiarity with risk-based qualification methodologies and lifecycle validation approaches
- Strong written and verbal communication skills
- Strong organizational skills and attention to detail
- Experience working in cross-functional project teams
- Experience supporting startup or qualification activities for sterile manufacturing capital projects (preferred)
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