Senior Quality Associate (Validation)
Core
Lead the design, execution, and maintenance of a robust and compliant Validation Program for pharmaceutical manufacturing, covering Site Validation Master Plans, Cleaning VMP, and Qualification (IQ/OQ/PQ) of facilities, utilities, equipment, and software.
Role type
Senior Quality Associate (Validation)
Builds
Compliant validation programs and qualified assets for biopharma clients
Domain
Pharmaceutical manufacturing / Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> infrastructure (validation of facilities, utilities, equipment, software)
Required skills
Validation program development, Qualification (IQ/OQ/PQ) and Process Validation (PV), Cleaning Validation, Risk assessment, Change control management, Audit support (customer/regulatory), e-Quality Management System usage, Life cycle management, Deviation investigation, SOP development
Preferred skills
Experience in cGMP pharmaceutical manufacturing, Microsoft Word/Excel proficiency, Third-party validation oversight
Technologies
e-Quality Management Systems, Blue Mountain (asset system)
Responsibilities
Lead design and development of Qualification and Validation programs compliant to PIC/s and quality risk management principles; Write, review, and approve validation procedures, master plans, protocols, and reports; Lead execution and monitoring of validation schedules; Provide quality oversight of asset systems and approve calibration/maintenance records; Lead decommissioning activities and process/cleaning validation; Review and approve change controls for recommissioning and new equipment; Provide training to employees on Validation; Collaborate with stakeholders including Project Management and Production; Report metrics related to Validation and assist with Quality Management Review.
Seniority
Senior, hands-on IC
