When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.
Location/Division Specific Information
Pharmaceutical Services Group – Oral Solid Dosage
How will you make an impact?
Develops and implements quality systems to assure that production processes, at all stages, are in compliance with established procedures (SOP’s), specifications and cGMP’S. Assure that all GxP related to any given Client are according to specific clients Quality Agreement.
What will you do?
Interaction with the Clients for all related quality aspects of the product manufactured by Patheon, part of Thermofisher.
Assure all quality systems following corporate policies, standard operating procedures (SOP’s) and product specifications.
Assures Quality SOP’s are current and comply with corporate policies, standard, and/or practices.
Develops and implements SOP’s related to quality systems/activities.
Provides coaching and training to QA personnel.
Supports continuous improvement philosophy by identifying and recommending corrective and preventive actions on findings and/or repetitive tendencies plant wide including clients.
Attends multidisciplinary operations meetings to share and communicate quality measurement information and provide support service as required.
Establishes measurement systems through use of statistical process control tools and effectiveness indicators such as “right the first time”, cycle time, among others indicators.
How will you get here?
Education
Bachelor’s degree, preferably with concentration in Science.
Experience
Three (3) to Five (5) years’ experience in quality related functions, preferably on a subcontract manufacturing environment.
Equivalency:Equivalent combinations of education, training, and relevant work experience may be considered.
Knowledge, Skills, Abilities
Strong understanding of quality and regulatory requirements in the pharmaceutical industry, including pharmaceutical GMPs and current Good Documentation Practices (cGDP).
Works on issues of moderate to high complexity in regards to compliance of processes and product within quality & regulatory compliance and data integrity.
Ability to work in a fast paced environment, able to multi-task and results-oriented.
Self-starter, mature, independent and dependable.
Effective time management and prioritization skills.
Proven excellence in customer service skills.
Excellent interpersonal skills to establish and maintain effective working relationships with internal and external customers.
Highly effective communication verbal and written in Spanish & English.
Expert presentation skills to present information to high level management, customers, and employees.
See above computer proficiency/software skills (i.e. Outlook, Excel, Word, PowerPoint, Empower, LIMS, Trackwise).
At Thermo Fisher Scientific, each one of our 75,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.
