Job Description
Responsibilities
• Provide interpretation and guidance on regulations, corporate, divisional, and site local procedures related to validation activities.
• Participate in the Corporate Validation Team to develop and revise validation procedures and templates, ensuring compliance with current regulatory standards and company objectives.
• Participate in corporate and local validation teams to discuss, provide feedback, and approve revisions to validation procedures.
• Represent validation at both internal and external audits.
• Work as part of several cross-functional local and global teams; visit and work on manufacturing sites as required, on a hybrid basis.
• Guide the definition of validation strategies for highly complex validation projects across multiple sites.
• Ensure that validation practitioners receive training and coaching to effectively support and perform validations for current and anticipated projects.
• Ensure appropriate systems are in place to evaluate changes to validated/qualified systems, maintaining their validated/qualified state.
• Utilize quality engineering tools, statistical methods, design development methods, process development/control methods, and process verification/validation planning to incorporate quality into new and existing products.
• Implement and develop the validation process for newly acquired sites as part of mergers and acquisitions teams.
• Work closely with product transfer, NPI, NPD, and AO teams.
• Lead validation continuous improvement projects.
• Implement lean and Six Sigma initiatives and lead teams to apply these methodologies.
• Act as the Subject Matter Expert responsible for at least two validation specialties and provide primary support for those specialties, such as Computer System Validation (CSV) or Qualification of Buildings, Facilities and Utilities (BFU).
Job Tags
Local area
Similar Jobs
Attollo
...Boat Captain Seeking a Boat Captain responsible for planning and executing maritime operations, including support for U.S. Navy Sea trials. This role involves safely operating and navigating vessels in varying weather conditions, conducting vessel inspections, performing...
Creative Speech Solutions
...multi-disciplinary pediatric therapy center with a dynamic team of speech-language pathologists, occupational therapists, and administrative support staff. CSS provides the following services: speech, language, occupational, feeding, and literacy therapies along with...
Providence Health and Services
...knit community, enjoy dazzling natural beauty, and year round outdoor adventurefrom exciting fishing and water activities to stress-... ...some additional questions from our Modern Hire system! Hours: Part Time (24 hours a week) Variable Shift Required Qualifications...
KnoWEwell, P.B.C.
...Volunteering with IONS IONS has a vibrant volunteer program that gives college students, professionals, and community supporters the... ...professional writing, and marketing assistance. Assistance with research projects (e.g., coding keywords and themes from archival...
Cornerstone Caregiving
...our clients, and we'd love for you to be part of our family! About the Role: We are... ...client in San Diego. She loves being outdoors and staying active! This is a perfect role... ...Accompanying client on walks and spending time outdoors together. Preparing meals as...