Search Results: 40 vacancies
...appropriately with Quality and Maintenance teams
Quality
# Work closely with QA Technician to ensure correct clean down and site GMP standards are achieved and maintained within the department.
# Monitor product quality continuously and react and report where issues...
...BSc, MSc, or PhD degree based in microbiology, biotechnology, biochemistry or similar discipline.
~5+ Year working in large molecule GMP manufacturing environment, operating in frontline microbiological support.
~ Demonstrated technical capability with high productivity...
€75k - €80k per annum
...automation and control systems comply with regulatory requirements.
- Implement change control, CAPA, and issue investigations for automated GMP systems and equipment.
- Search for and implement innovative solutions to improve system performance, reliability, and compliance....
...Contract Opportunity
Role Brief:
Perform all technical writer related tasks necessary for the creation and maintenance of quality GMP documentation in support of the Technical Operations Engineering and Automation Department.
Essential Duties and Responsibilities...
...records are reviewed in line with Batch Release procedures and are compliant before product is released to stock.
Ensure compliance with GMP practices i.e. gowning correctly, adhering to CMA rules, adhering to relevant line clearance procedures, following procedures and...
.../ROW CTDs)
~Is responsible for the final decision associated with batch certification
~Ensures that the principles and guidelines of GMP as stated in 2003/94EC, 2001/83EC, 536/2014 (repealing 2001/20/EC), associated EU GMP annexes, (e.g., Annex 13, Annex 16) and current product...
...Responsible for the completion of training in relation to the manufacture & shipment of product.
Ensure that a high standard of GMP and housekeeping is maintained in all manufacturing areas.
Adherence to all Environmental, Health and Safety requirements in accordance...
...service by continually reviewing best practice in relation to both commercial and quality issues and ensuring ethical work standards and GMP compliance.
Development, coaching, motivation, and morale of team members through effective team-building and use of reward and...
...Reporting to: Manager, Quality Systems
~• Change Analyst within the Agile Product Lifecycle Management (PLM) system. • Processing and GMP / GDP review of Change Orders (CO’s). • Ensure Change Orders are implemented fully. • Maintenance, control and distribution of Quality...
...implement training curriculums and team training plans.
Participates in the selection and hiring of Production Operators
Maintains GMP / 6S at a high level within the department through the involvement of all team members.
Lead / participate in continuous improvement...
...the manufacturing , warehouse and/or quality control operations. You will be responsible for QA business processes including support of GMP and GLP compliance, regulatory inspection readiness, Quality Plan and continuous improvement projects and will provide leadership and...
...engineering.
* 4 years’ experience in relevant engineering / asset management / maintenance leadership role.
* Prior experience in a GMP or medical device manufacturing environment.
* Prior experience in equipment and process validation activities.
* Good project...
Headcount Solutions Limited
Limerick
1 day ago
...standards, policies and procedures.
Maintains knowledge of current good manufacturing practices (cGMPs) and execution of any other GMP compliance related activities as required.
Continious Improvement Implementation.
Knowledge, skills and abilities:
Basic knowledge...
...Within this role you will be responsible for working with cross-functional teams to drive activities that will ensure a state of continuous GMP compliance in Regeneron IOPS and to build inspection readiness capability across the organization. This role will help to build...
Regeneron Pharmaceuticals, Inc
Limerick
1 day ago
...requirements by networking with operational areas.
• Manage events from initial response to follow-up.
• Establish and maintain safety, GMP and Environmental Standards.
People Management:
• Ensures training for the team is at or above the site goal.
• Ensure ongoing...
€40k - €50k per annum
...company in the Mid- West who are looking to significantly expand their Quality Control Operations. Seeking a candidate with min 9-12 months GMP industry experience (essential) along with a degree qualification in a Scientific discipline. A candidate with previous GMP food...
...qualification in production, manufacturing or mechanical engineering.
4 years' experience in relevant engineering role
Prior experience in a GMP or medical device manufacturing environment
Prior experience in equipment and process validation activities
N.B. It is essential...
...implementation of appropriate supporting documentation, SOPs and process work instructions compliant with current Good Manufacturing Practices (GMP).
• Leading technical improvements under the business’s Continuous Improvement Program (CIP).
• Provision of technical support to...
...skills and the ability to communicate across functions.
Strong knowledge of medical device quality standards ISO13485/FDA practices and GMP or similar regulated industry standards.
Proven problem-solving skills.
Good computer skills including knowledge of Microsoft®...
...Plan for the CMMS.
• Participate in and support site audits as the CMMS expert.
• Carry out internal audits and periodic reviews of GMP activities to ensure compliance, to identify improvements and lead the delivery of these improvements.
• Own & approve system access...
