Searching for C&Q Specialist with experience in the pharmaceutical and medical devices industries. The candidate must have solid GMP and regulatory experience with expertise in equipment validations.
Duties and Responsibilities
- Must possess a solid understanding of FDA Validation guidelines and industry best practice for this field; and be able to implement Validation standards on a daily basis
- Implements policies and procedures to validate/qualify equipment, systems, and processes in accordance with regulatory requirements and company manufacturing standards
- Generate new specifications based on new regulations required by the implementation of a new manufacturing process.
- Generates, executes, reviews, and complete qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria
- Prepares and coordinate qualification activities.
- Communicate with the staff and management on ways of implementing plans and recommendations.
Minimum of 2 years of experience
Bachelor in Science or Engineering (BSME, BSEE, BSChE, BSIE preferred)
Ultimate Solutions Corp is an Equal Opportunity Employer.
- Problem Solving
- Sense of urgency
- Detail Oriented
- Be flexible enough to travel to job sites when need arises.
- Willing to work overtime including weekend depending ion the nature of work available.
- Able to work with minimum or no supervision
- Strong interpersonal skills and must work in a team
- Fully Bilingual (English and Spanish)