, ISO, EN, and/or GMP standards Proven, strong detail-oriented work skills Proven ability to easily adapt to multi-task... of consultants and employees to work across the United States every year in contract, contract-for-hire, and permanent placement...
, Quality groups, the company’s CMO, Clinical Operations, GMP staff, and external consultants. -Develop project and budget... global quality systems that ensure compliance with FDA, ICH, GLP, GCP, and GMP requirements. Working closely with executive...
to contractors, consultants, and cross‑functional teams Supports inspections and defends system design, operation, and compliance..., capital project, Manufacturing engineering, commissioning, regulated environment, gmp environment, pharmaceutical Top Skills...
, BRCGS, EXCiPACT, FSSC22000, EFfCI, Kosher, Halal Implement GMP practices across QA Lead quality initiatives and training... auditors and consultants Oversee audit execution and ensure full compliance Review, approve, and issue audit findings...
and validation, and for determining product quality, purity, and stability. Analytical Operations (AO) is a non-GMP department... biotech or pharmaceutical industry is preferred. Knowledge of GMP compliance, experience with ELN, and intermediate...
to identify cost-efficient alternatives for electrical systems and equipment. Coordinate with engineers, consultants..., and subcontractors to clarify scope and pricing. Assemble and present estimates for various contract types (lump sum, GMP, cost...
contractors, on-site construction management team, and third-party consultants. Deliver monthly program reporting (schedule... (or equivalent) and pharma-specific training (GMP, validation) preferred. Familiarity with Current Good Manufacturing Practices...