Search Results: 47 vacancies
...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...
Limerick
3 days ago
...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...
...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...
...reliability, in a regulated Medical Device facility.
Ensure all maintenance and repairs are carried out in compliance to relevant SOP's and GMP requirements.
Update and maintain all maintenance records in an organised and efficient manner.
Provision of technical support...
...candidates who have a degree in Science (Chemistry Physics or related Life Science) and/or relevant experience.
Have knowledge of GMP standards
Have knowledge Laboratory safety standards.
Must have good communication skills both written and verbal.
Strong...
.../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...
...Previous work experience in Medical Device or Pharmaceutical environments is desirable.
-Strong aptitude for operating equipment in a GMP environment.
-Have the ability to work as part of a team and demonstrate a strong motivation towards teamwork.
-Must have demonstrated...
...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...
...perspectives.
Timely decision making.
Ability to respond to changing priorities.
Experience of working in strongly regulated GMP environment.
#LIDM2
Qualifications: Bachelor of Degree in Mechanical Engineering Preferred Competencies and Skills: Excellent oral...
...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...
...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...
...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...
...all safety-related procedures and practices.
Deliver on agreed KPIs and metrics.
Other duties as requested.
Requirements:
GMP experience is an advantage.
Demonstrate familiarity with written Standard Operating Procedures (SOPs) and Master Batch Records.
Excellent...
...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...
...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...
...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...
...Intermediates, Drug Substance & Drug Product in accordance with Analytical Standards and/or other approved protocols.
· To comply with all GMP and analytical procedures relevant to area of work.
· To adhere and comply with department High Performance Analytical Behaviours...
...regulatory agencies.
Executes laboratory work to characterise extraneous matter using SEM/EDX microscopy and FTIR techniques in support of GMP investigations.
In partnership with the Quality organization formulates and continually updates appropriate GMP procedures for...
...candidates who have a degree in Science (Chemistry Physics or related Life Science) and/or relevant experience.
Have knowledge of GMP standards
Have knowledge Laboratory safety standards
Must have good communication skills both written and verbal.
Strong...
