QA Technical Support/Compliance Specialist

Viatris • Vega Baja, PR

1d

About The Position

Viatris Pharmaceuticals LLC Viatris is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases. We have been included on number of award lists that demonstrate the impact we are making. This posting supports ongoing hiring needs and may be used to consider candidates for upcoming opportunities. Every day, we rise to the challenge to make a difference and here’s how the Technical Specialist role will make an impact:

Requirements

• Bachelor’s degree in pharmacy, chemistry, natural science, engineering, or other closely related areas.
• At least five (5) years of experience in the pharmaceutical industry with similar responsibilities.
• Knowledge of: GMP’s, validation principles and audit techniques.
• NDA, CMC and DEA/FDA regulations.
• Compendial methodologies (USP, EP, JP, CH ).
• Quality Systems.
• Be able to proactively assess and influence RA from different countries related to site registrations including changes.
• Proficient in computer software's such as Microsoft Office.
• Fully bilingual both, verbal and written (English and Spanish).

Responsibilities

• Perform sampling for testing of incoming materials (raw materials and packaging components) for the analytical (chemistry) and microbiological laboratory.
• Verify packaging components dimensional tests against approved component specifications and proof of text.
• Receive, dispatch and keep control of the retained samples room.
• Complete sampling of the water systems applying aseptic techniques.
• Perform statistical evaluations requested by Manufacturing and Packaging areas.
• Localize, identify, and segregate questionable materials along with Warehouse personnel.
• Perform job functions in accordance with all applicable Standard Operating Procedures (SOP), federal and state laws, Occupational Safety and Health Administration (OSHA) guidelines, health authority regulations, and departmental processes.
• Identifies and implements new technology, systems, and equipment for QC Laboratories.
• Provides technical support and training on new systems and techniques.
• Develops and/or modifies Standard Operational Procedures.
• Participates in the preparation, analysis, and control of assigned portion(s) of annual budget of his or her area.
• Identifies and implements cost improvements and avoidance (CIP) measures.
• Provide expert technical assistance diagnosing and troubleshooting complex hardware and software issues.
• Identifies and implements process improvement opportunities.
• Identifies, configures, validates, and implements gLIMS objects and /or structures (Standards and Reagents, Test Methods, Specifications, Instruments).
• Responsible for the coordination of activities required by QC (none testing activities) in the transfer of new products and or existing products.
• Review/approval of regulatory documentation. Protocols, reports and specifications.
• Responsible for the coordination of activities required in the Laboratories. Equipment’s Calibration, PM and non – routine services. Equipment’s Validation.
• Supports Method Validation and / or methods improvements.
• Acts as a liaison between technical development and QC during the transfer of new products.
• Available to work and provide support during weekends and after working hours.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level