C&Q Qualification 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 equipment / systems, and quantities to be validated / commissioned as part of this Project are listed as follows :

Commissioning and Qualification of :

a. Keyence

b. Vision System

All documentation required as part of the commissioning / qualification scope per equipment will be based on BMS global and local SOPs and approved templates. Some activities may require coordination with an interdisciplinary team that may include Infrastructure Technology (IT), IT / CSV, Manufacturing Validation Team (MT), Quality Control (QC), Environmental Health & Safety (EHS), Engineering / Facilities, and Quality Assurance (QA). Equipment commissioning / qualification deliverables is not limited to :   Qualification Deliverables Keyence Vision

Resources Qualifications :

• The resources for this RFP must meet the following minimum requirements to be considered :
• BS or higher in Chemistry / Biology / Microbiology / Computer Science / Information Systems / Engineering or related discipline.
• Background in pharmaceutical products manufacturing environment and in laboratories areas
• More than three (3) years of experience working with PLC’s, Industrial Computers with experience in commissioning and validating laboratory and manufacturing computerized systems in a manufacturing environment, and training in validation methodologies, technologies, and process control computer systems.
• Knowledge on computerized system with data collection software (database).
• Strong knowledge of cGMP, GAMP, SDLC, FDA, 21 CFR Part 11 and Data Integrity Regulations.
• Knowledge in MS Project Management and MS Visio programs.
• Experienced in Instrument Performance qualification, and method configuration
• Excellent skills writing commissioning / validation, and technical documentation in English and using MS Office applications.
• Bilingual (both English / Spanish)
• Must have access to infinity, ALM and veeva / Infinity.
• Qualification Team need to be established in the proposal and each resources qualification
• The resource should have experience with the specific task and equipment.
• Requires that the C&Q resource has performance qualification experience since that facilitate the generation of the Commissioning and Qualification technical document cycle and can expedite the E / E validation process if considered in the future to facilitate it. Resume should describe the experience, and experience references are required.

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.