Job Description

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

Review and approve product MPs.
Approve process validation protocols and reports for manufacturing processes.
Represent Quality on incident triage team.
Approve Environmental Characterization reports.
Release of sanitary utility systems.
Approve planned incidents.
Represent QA on NPI team.
Lead investigations.
Lead site audits.
Own site quality program procedures.
Designee for QA manager on local CCRB.
Review Risk Assessments.
Support Automation activities.
Support facilities and environmental programs.
Review and approve Work Orders.
Review and approve EMS/BMS alarms.
Approve NC investigations and CAPA records.
Approve change controls.
Provide lot disposition and authorize lots for shipment.
Perform review, approval and tracking of cGMP processes, procedures, testing (methods) in manufacturing, documents and records, batch record review, MES, EBR, SAP, Trackwise; including but not limited to Deviation's, CAPAs, and validations.
Actively engage in Continues Improvement initiatives, programs and projects.
Vigilant ensuring that changes that could potentially impact product quality are assessed according to procedures.
Certify that deviations from established procedures are investigated and documented per procedures.
Ensures that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements.
To be successful, you will require strong collaboration and partnership cross functionally to ensure the Quality Management System processes are executed in accordance with established procedures
Strategic advisor to senior management of quality, compliance, supply and safety risks
Supports internal/external audits and inspections as part of the audit/inspection management team including acting as Quality unit representative as needed
Accountable for assigned training adherence to permit execution of required tasks
Champion Continuous Improvement initiatives and projects
Provides support and oversight of New Product Introduction (NPI).

Preferred Qualifications

You will perform review, approval and tracking of cGMP processes, procedures, testing (methods) in manufacturing, documents and records, batch record review, MES, EBR, SAP, Trackwise; including but not limited to Deviation's, CAPAs, and validations.
Actively engage in Continues Improvement initiatives, programs, and projects.
Vigilant ensuring that changes that could potentially impact product quality are assessed according to procedures.
Certify that MES / EBR change control and new implementations complies with stablished procedures and specifications following current procedures.
Ensures that production records, MES /EBR testing validation process results are completed, accurate, and documented according to written procedures and cGMP regulations.
To be successful, you will require strong collaboration and partnership cross functionally to ensure the Quality Management System processes are executed in accordance with established procedures.
Strategic advisor to senior management of quality, compliance, supply, and safety risks.
To be fully engage in communication plan and maintain Management updated with progress of the project in Work Center Teams, Daily Meetings and in Quality systems forums.
Supports internal/external audits and inspections as part of the audit/inspection management team including acting as Quality unit representative as needed.
Accountable for assigned training adherence to permit execution of required tasks.
Champion Continuous Improvement initiatives and projects.
Provides support to Digital MES automated teams and provide quality oversight judgement during discussions.
Validated expertise in Quality Systems such as Non-Conformance, CAPA, and Change Control.
Experience in computer systems validation or computer systems quality assurance (medical device and/or consulting background technical proficiency).
Robust knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, Process Development and validation.
Experience with Validation of GxP applications, Validation Master Plan, Installation Qualification (IQ), Risk Assessment/GxP assessment, Operational Qualification (OQ), and Performance Qualification (PQ) Protocols, Test Scripts, and Completion/Summary Reports approvals as per the compliance requirements.
Validated experience as Quality Contact for complex projects involving document simplification.
Validated experience in Commissioning and Qualification.
Strong organizational skills, including ability to follow assignments through to completion.
Enhanced skills in leading, influencing and negotiating.
Demonstrate ability to interact with regulatory agencies.
Solid word processing, presentation, database, and spreadsheet application skills.
Strong communication (both written and oral) Spanish and English, facilitation and presentation skills.
Proven skill in working independently and to effectively interact with all levels throughout the organization.
Advanced data trending and evaluation.
Ability to evaluate compliance issues.

Education

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

Skills

Project management skills.
Strong organizational skills, including ability to follow assignments through to completion.
Initiate and lead cross functional teams.
Enhanced skills in leading, influencing and negotiating.
Strong knowledge in area of expertise.
Collaborate and coordinate with higher level outside resources.
Strong knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, validation and process development.
Demonstrate ability to interact with regulatory agencies.
Strong word processing, presentation, database and spreadsheet application skills.
Strong communication (both written and oral), facilitation and presentation skills.
Strong skill in working independently and to effectively interact with various levels.
Advanced data trending and evaluation.
Ability to evaluate compliance issues.
Demonstrate the client Values/Leadership Practices.

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.

* Ladders Estimates