We are seeking a highly skilled Senior Validation Specialist to join our Quality Assurance team. This role will be responsible for overseeing all validation activities to ensure compliance with current regulatory requirements, cGMP, and company SOPs.
Key Responsibilities:
* Oversight of validation activities including facilities, utilities, equipment, computerized systems, cleaning processes, manufacturing processes, storage areas, controlled temperature units (CTUs), and shipping processes
* Review and approval of validation documentation and associated data, including plans, URSs, quality risk assessments, protocols, and reports
* QA oversight of events/deviations, investigations, and change evaluations during qualification/validation activities
* Support in Regulatory inspections and Client audits
* Maintenance of validation status of the facility through provision of QA Validations expertise
Requirements:
* Deep knowledge of GxP regulations applicable to biologics manufacturing (e.g. EU-GMP, FDA, ISO)
* Knowledge of trouble shooting and problem-solving skills
* Knowledge of formal root cause analysis methods and tools
* Independent and self-motivated with strong planning, organisational, and time management skills
* Critical thinking skills and ability to operate across functional boundaries
* B.Sc. or B. Eng in a Scientific or Engineering related discipline (e.g. biochemistry, chemistry, engineering)
* Experience in a Quality Engineering/Quality Assurance/Quality Validations role for Biologics or related pharmaceutical/ medical device manufacturing in a FDA/ EU regulated environment
What We Offer:
* A dynamic working environment with opportunities for growth and development
* A competitive salary and benefits package
* The chance to work with a talented team of professionals