...Summary: The Quality System Specialist participates in maintaining site compliance of operations... ...Assurance, Facilities Maintenance, Engineering, Materials Handling, and QA Validation... ...compliance with company policy and local and international regulatory requirements.
Provision...
...responsible for the configuration, implementation, maintenance, and ongoing support of various IT applications and systems.
As a Senior IT Applications Analyst within Quality Systems a typical day might include, but is not limited to, the following:
Coordinating across business...
The Automation Utilities System Engineer would be accountable for the design, build and integration of the operating systems, application software... ..., Instrumentation/Calibration support to Facilities, Quality Assurance Team, Engineering and Operations
Administrating of...
...currently looking to fill a Quality Compliance Specialist - Change... ...products
Maintaining internal databases and tracking of partner... ...global alignment of processes, systems, and procedures
Partnering... ...’s in a scientific or engineering discipline or related field with...
Summary: The Quality Compliance Coordinator supports data trending, process monitoring, and system administration activities to ensure overall good health of the Quality Management System (QMS). This position will focus on Deviation, CAPA, Change Control and Quality Risk Management...
...compliance with Regulatory requirements and Regeneron internal procedures as well being the key liaison between the IT and Quality Assurance groups.
As a IT Compliance Analyst... ...Writing assistance with the completion of System Periodic Reviews.
Supports the execution of...
...this role you will be responsible for supervising the laboratory quality control testing of a variety of raw materials, products, in-... ...protocols, reports and SOPs
Assisting in the preparation for internal/customer/regulatory inspections
Proactively identifying and implementing...
...Industrial Operations and Product Supply (IOPS) Quality Auditing function. Quality (GMP) Auditing... ...criteria including, but not limited to, internal company policies and procedures and... ...performance and health of Quality Auditing systems and processes and presents metrics to...
...microbiological or biological analyses on raw materials, products, in-process materials, or stability samples in support of the company’s quality program.
Capturing data and documenting test results.
Completing test records and reviewing data.
Calibrating or verifying...
...new and renovated biopharmaceutical process equipment. Provides engineering support and problem solving for existing equipment and manufacturing... ....
Assists in investigations of process equipment and control system anomalies.
Implements corrective/preventative actions for...
...transferred and also providing investigation support.
As a DP MSAT Engineer a typical day might include, but is not limited to, the... ...deviations
Trending process performance and collaborates with internal and external teams to establish/improve process capability to...
Within this role you will be responsible for providing engineering support, troubleshooting, & subject matter expertise to the Facilities... ...for complex issues with plant equipment issues and associated systems, identifying and recommending corrective actions
Assisting in...
...equipment.
As a Mechanical Reliability Engineer, a typical day might include, but is not... ...policies for all equipment and systems, ensuring all planned routines are correctly... ...enforcing compliance with regulatory bodies and international standards
To be considered for this...
...decisions using real-time data and information.
As an Automation Engineer/Associate Engineer, a typical day might include, but is not... ...Environment
Overseeing migration of data from legacy systems to new applications
Acting as a Subject Matter Expert and the...
As an Automation Infrastructure Engineer you would be responsible for delivering and maintaining automation-based systems and solutions which provide for flexible, innovative, cost effective, compliant and quality-focused manufacturing of Biopharmaceuticals.
As an Automation...
...groups such as Maintenance, Process Sciences, Engineering to resolve process issues and... ...implementing improvements to the process or work systems in the suites.
Supports RFT programs... ...modifying process method files through the quality system.
Supports CAPA implementation...
...Providing leadership and ensuring continuous improvement to the Quality Training System and the GMP Program according to GMP and current industry... ...Participating in other quality systems activities such as internal audit, inspection preparation and change control as required...
...based records and the Computerized Maintenance Management System (CMMS)
Maintaining the physical condition and environment... ...Instrumentation/Calibration support to Facilities, Quality Assurance Team, Engineering and Operations
Adhering to and remaining current in assigned...
...follow, foster and implement on daily basis a quality culture and any other company... ...pharma, biotech, medical devices) in both internal and external regulatory audits.
Minimum... ...Education and Experience:
~ BS/BA in Engineering, Chemistry, or Life Sciences with 8+ years...
...closely with Manufacturing, Supply Chain, Quality Control, Quality Assurance, IT, and other... ..., Business Analytics, Computer Science, Engineering, or related field required with 5+ years... ...regulated environment and performing computer system assurance is preferred.
#REGNIELSM #LI-...
...well as coordinating work with appropriate internal departments, contractors, and external... ...timely completion of calibration related quality investigations
Acting as subject matter... ...you should have a BS/BA and 8+ years of engineering, maintenance/calibration and/or project management...
...Instrumentation/Calibration support to the Technical Operations, Quality Assurance, Engineering and Operations teams or any other area as the need arises.... ...for installing, testing and solving site electrical systems, PLC’s (Programmable Logic Controllers), PAT (Portable Appliance...
...developing direct reports
Working closely with Operations, Systems Support, and Quality functions to ensure Regulatory Compliance (FDA, DEA, OSHA,... ...considered for this opportunity you should hold a BS/BEng Engineering or related field desirable or be Qualified to National...
...and the customers are offered the highest quality standards and value for money, whilst at... ...delivery of same.
To ensure that security systems & procedures relating to the bar stock... ...team including performance appraisals, internal training schedules, disciplinary related...
...to ensure global alignment of processes, systems and procedures, unified communication to... ...monthly metrics for presentation; includes Quality Operations systems metrics
Acting as... ...opportunity you should have BA/BS in Science, Engineering, Technology & 8 + years of experience....
...center of excellence and establishing an international markets procurement team.
The global... ...of suppliers.
Interfaces daily with Quality Assurance and other functional areas to... ...Continually reassess’ Global Procurement systems and processes for adherence to cGMPs and...
...Centum Engineering are an electrical services company based in Dublin and Antrim, specializing in providing high-quality electrical solutions to industrial clients across Ireland and Mainland... ..., maintain, and repair electrical systems and equipment in the data centre....
...support during regulatory inspections and internal audits and work to ensure that all... ...regulatory trends
Defining and implementing systems, and metrics for maintaining regulatory compliance... ...Interfacing with customer/partner quality organizations
Participating on...
...qualification documentation for equipment, systems, and processes in accordance with... ...to, the following:
Leading a technical quality review team by developing appropriate plans... ...for this role you should have a BS/BA in Engineering, Chemistry, or Life Sciences with a minimum...
...budget while maintaining high standards of safety, quality, and efficiency.
Key Responsibilities:... ...role.
• A degree or diploma in Mechanical Engineering or a related field.
• Good understanding of mechanical systems, equipment, and tools.
• Strong leadership and...