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?

Responsible to maintain Quality Systems in compliance with current good manufacturing practices (cGMPs), global regulatory requirements, company policies, procedures and all other applicable regulations and guidelines. Also, to manage internal / external audits and host clients audits and regulatory inspections, including DEA. Additional to task under QS responsibilities such as, the Change Control system, be responsible for APRs, Quality Agreements, Stand Alone, CAPA System, Vendor Program and Customers Complaints.

What will you do?

• Evaluate site quality procedures/processes and work with multiple departments to implement efficient quality and current Good Manufacturing Practices (cGMPs), compliant processes across PDS, Commercial and Quality operations.

  • Review and approve protocols and reports

  • Manage change controls, stand-alone, CAPAs, approval and numbering.

  • Review, approval and propose revisions to (SOPs) operational procedures.

• Faced day to day interpretation of quality assurance documents, procedures and situations and be able to make decisions on issues in a timely manner.

• Communicate with multiples departments to provide support or direction for CAPA completions as part of observations.

• Keeps constant communication with multiple clients to provide regulatory requirements requests.

  • Prepare client request and certifications

• Accountable of Annual Product Review documents to ensure timely completion to clients.

• Hosting regulatory agency and clients audits, reports and CARF follow up

  • Performing Vendor/supplier Audits, reports and CAPAs follow up

  • Prepare Annual Product Review Reports

How will you get here?
Education

Bachelor’s degree, preferably with concentration in Chemistry

Experience
At least five (5) years’ experience in quality related functions, preferably on a subcontract manufacturing environment.

Experience reviewing and approving CAPA’s, change controls, APR reports, master batch records, protocols, among others

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.

• computer proficiency/software skills (i.e. Outlook, Excel, Word, PowerPoint, among others).

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.