Specialist Quality Complaints - Juncos, Puerto Rico - Mirus Consulting Group

Descripción

mirus Consulting Group is a local company based in Humacao, Puerto Rico that provides computer system validation and information technology consulting services to pharmaceutical companies and other organizations across the Island and parts of the United States. Its services include the assessment and validation of automation equipment, network infrastructures and business processes, as well as the involved project management.

Job Description

Primary responsibilities include: Supporting the product complaint system at client through; leading and managing product complaint investigations, performing data analysis and trending of complaint information to proactively detect signals and take appropriate actions in a timely manner.

Keep the complaints database updated as soon as factual information is available and summarize closed investigations into the database accurately.

Ensure complaint related investigations are concise, clear and science-based by reviewing and approving such investigations.

Follow-up on corrective actions derived from investigations through completion.

On occasion, depending on the nature and complexity of the complaint, the specialist may be responsible of conducting and documenting the investigation.

Therefore, the candidate must possess excellent writing skills that include closing the gap between a highly technical investigation into a simple and concise document that can be understood by non-technical reviewers.

May also include: Communication and escalation of complaints, site representation on the product complaint network and generation and issuance of closure letters to patients and business partners.

Education

Doctorate degree OR Master's degree and 3 years of directly related experience to the job OR Bachelor's degree and 5 years of directly related experience to the job OR Associate's degree and 10 years of directly related experience OR High school diploma / GED and 12 years of directly related experience.

Engineering, Sciences, but if another should have pharma industry experience.

Preferred Qualifications

Experience in manufacturing/packaging deviations, Root Cause Analysis, complaint investigations, project management and compliance.

Fully Bilingual

Skills

Strong project management skills, experience leading cross-functional teams, and the ability to handle multiple projects simultaneously is a must.

Excellent written and verbal communication skills, including facilitation and presentation skills.

Able to work in a team-oriented, matrix environment and work effectively with diverse departmental groups.

Be self-motivated, able to interface effectively with various levels, attentive to details and able to prioritize and meet deadlines, and must possess excellent leadership, problem solving, analytical, influencing and customer service skills to operate and deliver results in a matrix-managed GMP environment.

Computer literacy, independently understand, follow and implement instructions, work independently or as a team player and collaborate with outside resources, and the ability to evaluate issues, make decisions and determine when to escalate, as necessary.

This Company is an equal employment opportunity employer. We adhere to a policy of making employment decisions without regard to race, color, religion, sex, sexual orientation, national origin, citizenship, age or disability. We assure you that your opportunity for employment with this Company depends solely on your qualifications.