Search Results: 231 vacancies
...corrective actions, if necessary.
Support with Review and approval of Compliance documents e.g. Deviations, SCARS and CAPAs.
Conduct Routine... ...proactive in resolving issues which may arise.
Conduct annual GMP training to respective GMP Areas as and when scheduled....
...Hobson Prior is seeking a QC Compliance Specialist for a 6 month contract position based in Galway. This role will focus on quality control... ...Procedures, Raw Material Testing Procedures, and other QC associated GMP documents.
Display competency in technical areas such as...
...Quality and Compliance Specialist 2024-03-25 2024-03-26 TOBIN 200px 200px
TOBIN has an exciting role open for an experienced Quality and Compliance Specialist to join our team in our Galway office but with options at our Dublin, Limerick, Castlebar and Sligo offices...
...new milestones.
Ensures department adherence to regulatory and GMP requirements.
Promotes quality and customer satisfaction as a... ...proactively to reduce negative impact on product and projects. Ensures compliance in all of our practices and procedures.
Use the tools and...
...implementing, maintaining the quality management system, ensuring effective compliance in accordance with regulatory requirements.... ...competence.
~ Detailed knowledge of FDA QSR (21 CFR Part 820), GMP, MDSAP, IVDR and ISO 13485.
~ Solid communication and interpersonal...
...role with at least 2 years of this in Good Manufacturing Practice (GMP) environments (Life Sciences, Pharma, Medical Devices).
~ Based... ...on our expertise in industrial IT integration and regulatory compliance in support of global end users, OEM’s and Technology providers....
...within Alere, to the completion of routine assignments.
Works in compliance with established procedures and/or protocols. Identifies and... ...recognized Quality Management Systems (e.g. ISO9001/ ISO13485/ ISO14971/ GMP),
Awareness of relevant laws and regulations (e.g. CE/ FDA/...
...monitor company environmental safety programs and policies to ensure compliance with federal, state, and local environmental, health and safety... ...documentation.
Responsibility for assigned functional area GMP standards and compliance including the promotion of Quality awareness...
...engagement with company's critical Suppliers with regards to EU MDR compliance.
Build Strong relationships with suppliers (inclusive of 3rd... ...and efficiency of processes.
Overall responsibility for GMP standards and compliance within company’s Project Teams and Supplier...
...Lead the Materials Review Board (MRB) process
Address ongoing compliance
Establish inspection plans, frequencies and test methods for incoming... ...and quality systems improvements
Overall responsibility for GMP standards and compliance within manufacturing
Drive risk...
...cleanroom environment, adhering to Good Manufacturing Practice (GMP) and Good Documentation Practice (GDP) to ensure high standards are... ...procedures.
Assemble, repair, inspect, and test products in compliance with the MPI.
Record all necessary information accurately on approved...
...on building, inspection and testing of products.
Ensure full compliance with released Work Instructions and Procedures.
Complete written... ...were cleanroom-based).
Demonstrated experience with GDP & GMP standards is advantageous.
Work Experience/Training Provided...
...customers.
Reporting to the Engineering Manager – Projects & Compliance, the Project Engineer will apply strong fundamental engineering expertise... ...site. Effective management of projects ensuring compliance with GMP and regulatory requirements.
RESPONSIBILITIES:
· Management...
...qualification of pharmaceutical
equipment and building utilities within our site. Effective management of projects ensuring compliance
with GMP and regulatory requirements. The role will add additional expertise to the engineering function
by supporting compliance...
...Oversee and drive continuous improvement of product Quality and Compliance within TE Medical.
Establish and maintain a culture of continuous... ....
~7+ years of relevant Quality Operations experience in a GMP Manufacturing environment within the Medical Device/Pharma industry...
...Parking
Role:
Support the Quality Management Systems and maintenance of Good Manufacturing Practice (GMP),Good Documentation Practice (GDocP), Regulatory compliance and ISO certifications for the business.
Duties and Responsibilities:
Lead complaint management and...
...performance.
Support continuous improvement projects aligned with TEOA.
Manage staff, ensuring compliance with company policies and HR processes.
Drive compliance in GDP & GMP within manufacturing lines and teams.
Implement improved practices and cost reduction for...
...and implement strategies to optimize production processes and enhance efficiency.
Quality Assurance: Ensure compliance with Good Manufacturing Practices (GMP) and drive continuous improvement initiatives to uphold product quality standards.
Maintenance Management: Proactively...
...improve quality of manufactured product and overall effectiveness and efficiency of processes.
Overall responsibility for GMP standards and compliance within Aerogen’s Project Teams and Supplier Engagement.
Qualifications & Experience:
BE/BS Degree.
A Post-...
...adherence to the highest standards of performance and regulatory compliance.
Engage with vendors and suppliers regularly, maintaining efficient... ...and proficiency in CAD (Solidworks), medical device regulations (GMP, QSR, ISO), and MS Office.
Strong analytical and problem-...