We are hiring a Validations Manager. The Validations Manager will manage the Company’s Validation department and certain aspects of the Quality Assurance department. Validation responsibilities and activities include, management of Validation Specialists and company master validation plan, to ensure all company processes, equipment and products are properly verified and validated per GMP, 21CFR part 820 and ISO 13485 requirements. Quality Assurance responsibilities to include, but are not limited to, assisting in the management and improvement of product quality, quality systems, supplier/material quality, and audit actions. The person in this role will ensure that required quality exists in all QA and Validations functions as prescribed to ISO13485, QSR, Brazil, MDD 93/42, IVDD 98/79/EC, Canadian Device Regulations, Australia, and other regulations as appropriate for where company registers and distributes product.
- Responsible for creating a Master Validation Plan every year for the organization and responsible to ensure execution as planned
- Manage team of Validation Specialists to ensure all aspects of company equipment, processes and products are verified and validated
- Manage the validations schedule (and new validation requests) to ensure that established turnaround times and due dates are met
- Schedule and coordinate execution of validation activities with various departments
- Develop Validation Master Plans to capture the validation lifecycle, including, but not limited to, URS, FRS, FAT, SAT, IQ, OQ, PQ, method and cleaning validation, as appropriate
- Approve, implement and coordinate all installation, operation and performance qualification of equipment, process, studies, cleaning and method validations
- Create trend analysis to ensure on time and accurate validation activities
- Meet established Key Performance Indicators (KPI) and take action depending on results
- Assist in management of supplier and raw material qualification program including maintenance of databases and records, and change notification
- Provide customer support in areas such as completion of surveys, providing raw material information, and related QA support
- Assist in activities related to the preparation for and conduct of FDA and Notified Body inspections and customer audits
- Assist and support Quality Systems management in the conduct of daily operations of the department and within the Company as required
- Trend and Analyze KPI’s; Provide input as to appropriate corrective and preventive actions and suggest plans for improvement
- BS in Microbiology/Chemistry/Biology/Chemical Engineering or equivalent experience
- A minimum of ten (10) years of Quality Assurance/ Validation in medical device manufacturing or equivalent.
- A minimum of four (4) years in a managerial position
- Proficiency in current versions of MS Word, Excel
- Excellent communication and collaboration skills
- Knowledge of current industry regulations, i.e. detailed understanding of 21CFR211-cGMP, FDA QSR 820, ISO13485, Canadian, Brazil and Australian Medical Device Guidelines.
- Knowledge of FDA and other regulatory authorities’ guidelines on general principles of process validation
- Knowledge of specific validations, including, but not limited to, cleaning processes, aseptic filling, analytical methods, process, performance, software
Principals only. No recruiters please.
FUJIFILM Irvine Scientific is an equal opportunity employer. All qualified candidates will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran status, or any other characteristic protected by applicable federal, state, or local law.