JOIN OUR TEAM!
PharmaLex is a highly successful and growing consulting company for the Healthcare industry around the world. PharmaLex offers professional development, plus a stimulating and collaborative work environment. We are committed to providing exciting career opportunities in an atmosphere that values trust, respect, teamwork, creative talent, enthusiasm, and diligence.
Location - Juncos, PR
Requirements
- Process and Computerized Systems Validation
- Experience in FDA regulated industries
- Excellent verbal and written communication skills (English and Spanish).
Education Required: Bachelor's degree in Engineering
Years’ Experience Required: 1-3 years
JOB DESCRIPTION
Develops, modifies, applies, and maintains standards for software systems quality operating methods, processes, and procedures. Conducts evaluation of software systems activities including requirements, design, development, documentation, integration, test, verification, and validation. Provides verification and validation of software system requirements, traceability, and testability. Work with peers to address process changes to existing work instructions and/or standard operating procedures.
Responsibilities may include the following and other duties may be assigned.
Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product.
Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.
PharmaLex is an Equal Opportunity Employer.
What We Do
PharmaLex is a leading provider of specialized services for the pharma, biotech and medtech industries.
We guide you from early strategic planning activities and non-clinical requirements through clinical development, regulatory submission processes and post-approval/maintenance post-launch activities. Our experts use technology enabled solutions to support you through the entire product lifecycle. We deliver exceptional results - going above and beyond the standard to deliver tailor-made solutions worldwide.
The PharmaLex Group now has over 3000 employees, with 68 offices in 32 countries and more than 1000 satisfied clients worldwide.
