Associate Director of Validation
4 months ago
The Associate Director of Validation will lead and support the qualification and compliance readiness of our new global center for the warehousing, processing, packaging, and worldwide distribution of human blood plasma and plasma derivatives for therapeutic use.
The Associate Director of Validation will be responsible for direct leadership over the Validation and Air Filtration System departments, focusing on maintaining and improving the robustness and availability of our Equipment, Facilities and Systems to meet Grifols global business and customer needs while ensuring compliance with applicable quality and regulatory requirements, utilizing modern validation principles and standards.
KEY RESPONSIBILITIES
PERSON SPECIFICATION
Minimum 10 years relevant experience in pharmaceutical/biologics operations including Validation management, Processing and packaging operations and qualification, operation and continuous monitoring of new manufacturing facilities. Expertise in Validation practices, philosophy’s and knowledge of cost drivers for plasma and plasma derivatives facility qualification and upkeep Experience in strategic business continuity planning, and risk assessments a plus. Strong knowledge of cGMPs and industry guidelines, as well as international regulatory guidelines required to support and maintain the production, packaging and distribution of human blood plasma from a validation and qualification perspective. Excellent verbal and written communication, must be able to read, write and speak English. Strong interpersonal skills with ability to interact with all levels of personnel in a professional manner. Demonstrated leadership skills with ability to motivate, guide, train, coach and develop subordinates. Strong organisational, analytical, problem solving and spreadsheet skills, including cost modelling. Ability to analyse detail and perform structured decision making daily. Ability to manage multiple projects simultaneously, meet deadlines, and handle and everchanging, fast paced critical work environment. Ability to read and understand specification sheets, drawings, regulations (cGMP, QS, ISO). Willing to travel domestically and internationally up to 10%. Bachelor’s degree in Mechanical, Chemical Engineering, Manufacturing Engineering, Validation or Operations Management, Material Science or closely related scientific/technical discipline or qualificationOur Benefits Include:
Highly competitive salary Group pension scheme - Contribution rates are 5% employer and 5% employee Private Medical Insurance for the employee Ongoing opportunities for career development in a rapidly expanding work environment Succession planning and internal promotions Education allowance Wellness activities - Social activities eg. Golf, Padel, Summer EventsWe understand that self-doubt can hold talented individuals back from applying for opportunities. We encourage everyone who meets the qualifications to apply – we're excited to hear from you
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Location: Dublin:Grange Castle (Dublin)
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