CSV Specialist
Gurabo, PR · On-site
The CSV Specialist will be responsible for managing and executing all activities related to ... Support system implementations, migrations, and upgrades, collaborating closely with IT, QA, and ...
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CSV Specialist
Gurabo, PR · On-site
The CSV Specialist will be responsible for managing and executing all activities related to ... Support system implementations, migrations, and upgrades, collaborating closely with IT, QA, and ...
... and management staff within manufacturing, process development, and quality. * Proficiency in GDP (Good Documentation Practices) on a regulated environment * Knowledge in systems/Tools: Trackwise ...
... and management staff within manufacturing, process development, and quality. * Proficiency in GDP (Good Documentation Practices) on a regulated environment * Knowledge in systems/Tools: Trackwise ...
Project Manager
San Juan, PR · Hybrid
$130K/yr
Manage endtoend project delivery, ensuring quality systems, programme alignment, and timely completion of key milestones and deliverables. * Oversee budgets, risks, and longterm functional ...
Project Manager
San Juan, PR · Hybrid
$130K/yr
Manage endtoend project delivery, ensuring quality systems, programme alignment, and timely completion of key milestones and deliverables. * Oversee budgets, risks, and longterm functional ...
CSV Specialist
Gurabo, PR · On-site
The CSV Specialist will be responsible for managing and executing all activities related to ... Support system implementations, migrations, and upgrades, collaborating closely with IT, QA, and ...
CSV Specialist
Gurabo, PR · On-site
The CSV Specialist will be responsible for managing and executing all activities related to ... Support system implementations, migrations, and upgrades, collaborating closely with IT, QA, and ...
... system and physical in adherence to cGMP's, company policies and procedures according to the ... Informs QO management of the status of operations and reports unusual situations and/or problems.
... system and physical in adherence to cGMP's, company policies and procedures according to the ... Informs QO management of the status of operations and reports unusual situations and/or problems.
Experience with SOP modernization, document management systems, or quality process transformation programs.
New
Experience with SOP modernization, document management systems, or quality process transformation programs.
New
Manufacturing Manager
Arecibo, PR · On-site
... quality issues, daily previous production, actions and usage of IIOT system) thru IIOT Dashboard ... Ability to manage both tactical execution and strategic priorities simultaneously. * Strong ...
Manufacturing Manager
Arecibo, PR · On-site
... quality issues, daily previous production, actions and usage of IIOT system) thru IIOT Dashboard ... Ability to manage both tactical execution and strategic priorities simultaneously. * Strong ...
Specialist QA
Juncos, PR · On-site
Attends GMP Buildings Quality system forums and or Management Review meetings to present environmental and critical utilities data and recommend actions based on the data evaluation. * Ensures that ...
Specialist QA
Juncos, PR · On-site
Attends GMP Buildings Quality system forums and or Management Review meetings to present environmental and critical utilities data and recommend actions based on the data evaluation. * Ensures that ...
Attends GMP Buildings Quality system forums and or Management Review meetings to present environmental and critical utilities data and recommend actions based on the data evaluation. * Ensures that ...
Attends GMP Buildings Quality system forums and or Management Review meetings to present environmental and critical utilities data and recommend actions based on the data evaluation. * Ensures that ...
PR · On-site
Project Manager PharmEng Technology has been providing quality services to leading manufacturers of ... Our specialists hold expertise in Commissioning & Qualification, Validation, Quality Systems ...
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PR · On-site
Project Manager PharmEng Technology has been providing quality services to leading manufacturers of ... Our specialists hold expertise in Commissioning & Qualification, Validation, Quality Systems ...
Project Manager
Dorado, PR · On-site
Manage the performance of projects or significant subsystems associated with new products by ... Strong knowledge of FDA Quality System Regulation (21 CFR Part 820), Good Manufacturing Practices ...
Project Manager
Dorado, PR · On-site
Manage the performance of projects or significant subsystems associated with new products by ... Strong knowledge of FDA Quality System Regulation (21 CFR Part 820), Good Manufacturing Practices ...
Manage the performance of projects or significant subsystems associated with new products by ... Strong knowledge of FDA Quality System Regulation (21 CFR Part 820), Good Manufacturing Practices ...
Manage the performance of projects or significant subsystems associated with new products by ... Strong knowledge of FDA Quality System Regulation (21 CFR Part 820), Good Manufacturing Practices ...
Manage the performance of projects or significant subsystems associated with new products by ... Strong knowledge of FDA Quality System Regulation (21 CFR Part 820), Good Manufacturing Practices ...
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Manage the performance of projects or significant subsystems associated with new products by ... Strong knowledge of FDA Quality System Regulation (21 CFR Part 820), Good Manufacturing Practices ...
Ensure audits assess both compliance to regulations and effectiveness of quality management systems. * Drive consistency in audit methodology, planning, execution, reporting, and follow-up globally.
Ensure audits assess both compliance to regulations and effectiveness of quality management systems. * Drive consistency in audit methodology, planning, execution, reporting, and follow-up globally.
PR · On-site
Knowledge of ISO 9001 Quality Management Systems. * Experience handling CAPA processes, audits, and document control. * Knowledge of root cause analysis tools and methodologies. * Proficiency in ...
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PR · On-site
Knowledge of ISO 9001 Quality Management Systems. * Experience handling CAPA processes, audits, and document control. * Knowledge of root cause analysis tools and methodologies. * Proficiency in ...
... for an Enterprise Platform Systems - Quality Engineering Test Analyst. This is an onsite ... with DT management and application teams to drive remediation actions and improve testing ...
... for an Enterprise Platform Systems - Quality Engineering Test Analyst. This is an onsite ... with DT management and application teams to drive remediation actions and improve testing ...
... for an Enterprise Platform Systems - Quality Engineering Test Analyst. This is an onsite ... with DT management and application teams to drive remediation actions and improve testing ...
... for an Enterprise Platform Systems - Quality Engineering Test Analyst. This is an onsite ... with DT management and application teams to drive remediation actions and improve testing ...
$69K - $90K/yr
Support and participate in customer, external, and internal audits, while ensuring compliance with Henkel quality policies, standards, and management systems. * Provide plant-wide quality assurance ...
$69K - $90K/yr
Support and participate in customer, external, and internal audits, while ensuring compliance with Henkel quality policies, standards, and management systems. * Provide plant-wide quality assurance ...
PR · On-site
$64K - $83K/yr
Utilize precision measuring instruments, including calipers and vision inspection systems, to ... Document and report defects to Engineering Teamsand Managers. Requirements: * BSdegree in ...
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PR · On-site
$64K - $83K/yr
Utilize precision measuring instruments, including calipers and vision inspection systems, to ... Document and report defects to Engineering Teamsand Managers. Requirements: * BSdegree in ...
Quality Engineer
Sabana Grande, PR · On-site
$69K - $90K/yr
Support and participate in customer, external, and internal audits, while ensuring compliance with Henkel quality policies, standards, and management systems. * Provide plant-wide quality assurance ...
Quality Engineer
Sabana Grande, PR · On-site
$69K - $90K/yr
Support and participate in customer, external, and internal audits, while ensuring compliance with Henkel quality policies, standards, and management systems. * Provide plant-wide quality assurance ...
Quality Systems Manager information
What are the key skills and qualifications needed to thrive as a Quality Systems Manager, and why are they important?
To thrive as a Quality Systems Manager, you need strong expertise in quality management principles, regulatory compliance, and process improvement, typically supported by a degree in engineering or a related field. Familiarity with ISO standards (like ISO 9001), quality management software, and certifications such as Six Sigma or ASQ Certified Manager of Quality/Organizational Excellence are commonly required. Leadership, analytical thinking, and effective communication are crucial soft skills for coordinating teams and driving continuous improvement. These skills and qualifications are essential to ensure consistent product quality, regulatory adherence, and overall organizational efficiency.
What does a Quality Systems Manager do?
A Quality Systems Manager is responsible for developing, implementing, and maintaining a company's quality management systems to ensure compliance with industry standards and regulations. They oversee quality assurance processes, conduct audits, and work with different departments to improve procedures and product quality. Quality Systems Managers also manage documentation, train staff on quality standards, and analyze data to identify areas for continuous improvement. Their goal is to ensure that products and services consistently meet customer and regulatory requirements.
What is the difference between Quality Systems Manager vs Quality Assurance Manager?
| Aspect | Quality Systems Manager | Quality Assurance Manager |
|---|---|---|
| Primary Focus | Developing and maintaining quality management systems and processes | Overseeing product testing and ensuring quality standards are met during production |
| Certifications | ISO 9001 Lead Auditor, CQE | ASQ certifications, QA certifications |
| Work Environment | Quality management departments, compliance teams | Production lines, testing labs |
| Industry Usage | Manufacturing, healthcare, aerospace | Manufacturing, software, healthcare |
While both roles focus on quality, the Quality Systems Manager primarily manages the overall quality management system and compliance, whereas the Quality Assurance Manager concentrates on product testing and ensuring quality during production. Understanding these differences helps in selecting the right career path or hiring the appropriate professional.
What Does a Quality Systems Manager Do?
As a quality systems manager, your primary responsibilities are monitoring the production processes and ensuring factory machinery/goods are within company and industry requirements. Your duties include weighing, sampling, or testing products for quality and functionality. You may also report the results of quality control tests. You monitor the equipment and people involved, and help with the development and implementation of improved management systems. You are also in charge of creating a standard operating procedure for the specific plant where you work. You check that everything is running at full efficiency and the quality of merchandise is standardized.
How does a Quality Systems Manager typically collaborate with cross-functional teams to drive continuous improvement?
A Quality Systems Manager works closely with departments such as manufacturing, engineering, regulatory, and supply chain to ensure that quality standards are consistently met and improved. They often lead or participate in cross-functional meetings to identify process gaps, analyze data, and develop corrective and preventive action plans. Effective communication and project management skills are essential, as the role involves aligning diverse teams toward common quality objectives and facilitating training or audits to support compliance and improvement initiatives.
More about Quality Systems Manager jobs
What are the most commonly searched types of Quality Systems jobs in Puerto Rico? The most popular types of Quality Systems jobs in Puerto Rico are:
What job categories do people searching Quality Systems Manager jobs in Puerto Rico look for? The top searched job categories for Quality Systems Manager jobs in Puerto Rico are:
What cities in Puerto Rico are hiring for Quality Systems Manager jobs? Cities in Puerto Rico with the most Quality Systems Manager job openings:
Full-time
Posted 24 days ago
Job description
mîrus 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 project management involved.
Position Summary:
The CSV Specialist will be responsible for managing and executing all activities related to Computer System Validation (CSV) throughout the full validation lifecycle, ensuring compliance with FDA, cGMP, 21 CFR Part 11, GAMP 5, and corporate standards. This position will support system implementations, upgrades, and periodic reviews across manufacturing and quality systems, with a strong focus on parenteral processes and regulated environments.
Key Responsibilities:
Qualifications & Requirements:
Position Summary:
The CSV Specialist will be responsible for managing and executing all activities related to Computer System Validation (CSV) throughout the full validation lifecycle, ensuring compliance with FDA, cGMP, 21 CFR Part 11, GAMP 5, and corporate standards. This position will support system implementations, upgrades, and periodic reviews across manufacturing and quality systems, with a strong focus on parenteral processes and regulated environments.
Key Responsibilities:
- Develop, review, and execute CSV deliverables including Validation Plans, Risk Assessments, URS, FRS, IQ/OQ/PQ protocols, and Validation Summary Reports.
- Ensure that computerized systems meet data integrity and regulatory compliance requirements.
- Support system implementations, migrations, and upgrades, collaborating closely with IT, QA, and Manufacturing teams.
- Participate in impact assessments, change control activities, and periodic system reviews.
- Provide technical and compliance support during internal and external audits.
- Maintain validation documentation in alignment with company quality systems and GAMP 5 guidance.
- Support troubleshooting, deviation resolution, and CAPA implementation related to validated systems.
- Promote continuous improvement and standardization of CSV practices across site operations.
Qualifications & Requirements:
- Bachelor’s Degree in engineering, Computer Science, or a related scientific discipline.
- Minimum of 5 years of hands-on experience in Computer System Validation within the pharmaceutical or biotechnology industry.
- Strong knowledge of CSV lifecycle methodology, 21 CFR Part 11, Annex 11, and GAMP 5.
- Experience with parenteral operations or aseptic manufacturing environments preferred.
- Excellent documentation, communication, and teamwork skills.
- Fully bilingual (Spanish/English) preferred.