Project Management & Execution Services

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:

The resource will support the Supply Chain area during the implementation of the "Update to site Change Control procedure associated with printed component changes" execution project.

Requirements:

• Bachelor's degree in science (Chemical, Engineering, Biology, Pharmacy or Microbiology)
• Six (6) years of experience in project management, investigations or relevant roles and responsibilities in a pharmaceutical industry
• Strong knowledge of relevant GMP, FDA, 21 CFR Part 11 and Data Integrity Regulations (Risk
• Assessment, Data Mapping etc), EU regulations and the ability to interpret and apply them for intended use.
• Fully bilingual (Spanish/English) communication skills, both written and verbal.
• Self-motivated, creative and teamwork oriented
• Technical and scientific capability to make firm decisions and recommendations
• Excellent interpersonal skills and the ability to interact with people at all levels
• Effective communication Skills
• Sense of urgency and analytical thinking
• Proficient knowledge of computer systems (Microsoft Office etc.) with data collection software (database) and applications like Infinity and SAP
• Solid ability for analyzing data detecting deviations, inconsistencies and interpret sampling test results
• Proficient knowledge of problem solving and root cause analysis methodologies (i.e. Kepner Tregoe)
• Willing to work irregular hours, rotative shifts, weekends and holidays when needed.

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.