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Validation Manager
4 months ago
Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.
At Grifols, we believe that diversity adds value to our business, our teams, and our culture. We are committed to equal employment opportunities that foster an inclusive environment.
The Validation Manager will lead the Validation Department in the start-up, commissioning, qualification and validation of the New Albumin Purification and Aseptic Filling Plant. This will include the completion of conformance lots to meet FDA Submission filing timelines, as well as audit readiness and commercialization of the new under the Validation managers leadership will be the existing Packaging and Temperature Controlled Warehousing facility.
What your responsibilities will be:
Lead the effective planning, organization, development and resourcing of the Validation Department to ensure a successful start-up strategy is in place. Directs and oversees the qualification and validation of all relevant facilities, utilities, equipment, and processes to meet project timelines Ensures the review of specifications, drawings and documentation are critically assessed, participates in installations inspections, plans and coordinates performance testing, and writes, reviews and approves validation documents (protocols, reports, as required. Develop and lead Qualification timelines to ensure Project Team are aligned and committed to achieving overall project schedule Participate in regulatory and internal inspections/audits including providing written responses as applicable for areas of responsibility. Assists with activities and provides guidance to contract specialists when needed in support Participates during all phases of validation, FAT's, SAT's, etc and evaluates projects, provides guidance and technical information to others. Supports Installation Qualification activities in Engineering, checks operating parameters during Operational Qualifications, and coordinates with testing participants (Quality, Production) during Performance Qualifications, Performance Validation and Maintain current knowledge of regulatory and industry standards, trends and advancements through independent reading and training. Responsible for development of staff, including training and motivating in a manner that promotes the achievement of Company and department business goals and objectives. Leads the cross functional review of engineering drawings (Pipe & Instrument Designs, construction, as-built, flow diagrams) for compliance to Good Manufacturing Practices/ Validation principles. Demonstrates technical knowledge and ability to changing circumstances. Displays flexibility with assignments in different units Demonstrates ability to influence others effectively Makes decisions with designated assignments that influence the goals of the department Produces anticipated results that contribute to business or technical goalsWhat you will bring to the role:
Previous Pharmaceutical/ Bioscience/ Medical Device experience Excellent oral and written communication skills 8+ years Validation management experience BA/BSc in an Engineering or Scientific Discipline Demonstrated leadership skills with ability to motivate, guide, train, coach and develop subordinates. Strong organizational, analytical, problem-solving, skills. Ability to analyze detail and perform structured decision-making on a daily basis. Ability to manage multiple projects simultaneously, meet deadlines, and handle an ever changing, fast paced critical work environment. Ability to read and understand specification sheets, drawings, regulations (cGMP, QS, ISO). Demonstrates technical knowledge and ability to changing circumstances. Displays flexibility with assignments in different units Demonstrates ability to influence others effectively Makes decisions with designated assignments that influence the goals of the department Produces anticipated results that contribute to business or technical goalsDesirable
Knowledge of aseptic processing and filling, sterilization, GMP regulations and Quality operations an added advantage. Facility Start up experience an advantage Willing to travel domestically and internationally as requiredOur 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 Events If you're interested in joining our company and you have what it takes, then don't hesitate to apply.
We look forward to receiving your application.
#LI-FD1
Location: Dublin:Grange Castle (Dublin)
