Average salary: €34,000 /yearly
More statsSearch Results: 42 vacancies
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...
...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
6 days ago
...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...
...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...
.../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...
...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...
...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...
...Supporting equipment investigations to drive reliability and performance
Ensuring all areas of responsibility are compliance with GMP regulations
Promoting and ensuring safe working environment
Coaching and developing direct reports
Working closely with Operations...
...policies, technical reports/protocols, change controls, etc. in support of cGMP activities
Supports development of sampling plans for GMP batches related to lot release, stability and characterization
Works with Manufacturing to ensure robust procedures are utilized for...
...systems, electronic batch records, or manufacturing execution systems
Experience in a manufacturing environment
Experience in a GMP environment
Find working in an ambiguous environment with changing priorities exciting
Enjoy exploring technology and asking process...
...contractors on approved supplier list in order to supplement full time employees; Submitting purchase requisitions as required
Ensuring that GMP and Regulatory requirements are complied with as evidenced by internal audits and inspections from Government Agencies
Directing,...
...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...
...working relationship is maintained with internal teams and external logistics partners to deliver on the above business requirements in a GMP environment, functioning as part of Supply Chain Logistics and be responsible for the operational support for internal and external...
...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...
...completion of an interview process. Additional Experience:
~8-10+ years of managing employees and budgets
~7-10+ years of experience in a GMP manufacturing environment and experience in a biotech/pharma environment
~ Experience with IT Compliance guidelines as per GAMP 5....
...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...
...training requirements to management as required
Facilitating departmental training requests ad hoc
Coordinating and assist with annual GMP training initiatives
Promoting continuous improvement of all training programs
To be considered for this opportunity you should...
