Average salary: €22,430 /yearly
More stats ...expected to begin in May and June and will last approximately three to four months.
Bringing in significant experience in pharmaceutical GMP settings, you will support a small permanent team with key qualification activities. Given, the size of the team, you will most...
Cork
21 days ago
£51.3k - £59.8k per annum
...appropriate field of study or equivalent work experience. You will also require the following:
*
5+ years of Automation Experience in a GMP environment
*
Automation PLC experience required in Siemens S7, Allen Bradley PLCs
*
Familiarity with other serialization...
Cork
15 days ago
£ 345 - 517 per day
...functional teams to execute validation deliverables.
Expertise in QC testing, laboratory processes, and experience within a pharmaceutical GMP compliant analytical lab.
Design, develop, and execute quality deliverables such as Validation Protocols, CSV Regulatory Risk...
Cork
28 days ago
...documentation, e.g., Design Spec, Configuration Spec, Testing, Security Plan, Test Summary Report, in accordance with site procedures and GMP guidelines
*
Review software release notes.
To apply for this CSV Engineer role, you will need a minimum of 3 years of experience...
Cork
15 days ago
...Execution of IOQ protocols for lab analytical instruments.
* Generation of risk assessments.
* Be a key SME for the AIQ process for all GMP audits
The Ideal Candidate
* A BSc in Engineering, Computer Science, or other technical degree
* 5+ years’ experience in a...
Cork
15 days ago
...Technology.
~2/3 years’ experience in a manufacturing environment or equivalent with direct experience in a QA environment (preferably GMP regulated).
~ Experience in the medical device industry is an advantage.
~ Experience on an automated/high volume line an advantage...
...replenishment
Deal with ad hoc material requests as required
Maintain cleaning materials to high standards
Work in cleanroom following GMP and SOP's
Liaise with manufacturing staff on requirements on a daily basis
Deal with customers’ requests
Collaborate with...
...process equipment ie. supply, start-up, sampling, running checks, first level troubleshooting, dismantling and cleaning. Manufacture to GMP standard.
Are you intrigued ? Do you want to learn more?
Responsibilities:
Respect the rules of Quality Assessment...
...qualification desirable.
* 3-5 years’ experience working in an EPA regulated environment essential.
* Knowledge and experience working in a GMP regulated environment preferred.
* Solid understanding of EHS legislation & ISO 14001 requirements.
* Ability to review and update...
Team Horizon
Cork
17 hours ago
...Bachelor’s Degree in Engineering or Science fields
Minimum of 5 years’ experience in manufacturing environment.
Good knowledge with GMP, ISO 13485, 21 CFR Part 820 standards
Working knowledge of FMEA, Validation Programs and SPC processes in a highly regulated...
...Technology, Chemistry, Pharmacy or equivalent scientific degree
Minimum 3 year' experience in process support role on the shop floor of GMP manufacturing and/or QA/QC.
Proven process understanding (Pharma, GMP, Regulatory aspects).
Fastnet has a strict...
...the Pharmaceutical industry.
~ Experience of data handling and applied statistics is a must.
~ Proven process understanding (Pharma, GMP, Regulatory aspects).
Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to...
...ideal Production Manager looks like:
~5+ years' experience in production management or senior supervisory role.
~ Strong awareness of GMP and Health, Hygiene & Safety requirements.
~ Honours degree in Food Science/Process Engineering or related discipline.
~ Excellent...
...factory experience and demonstrated experience of working safely in a regulated environment.
Good IT skills (computer-controlled equipment would be advantageous)
Positive attitude to work
Knowledge of GMP and demonstrated implementation of GMP regulations or similar...
...and co-ordinate test samples
• Lead and support customer and regulatory audits, including preparing the plant for audits
• Carry out GMP (Hygiene) and Quality System audits and work with Ops and Manager to action and address the issues,
• Co-ordinate and prepare for...
...This position has full responsibility for raw material, in-process & finished goods, environmental analysis and reporting in line with GMP.
Key Responsibilities
Conduct Q.C. laboratory tests and analysis.
Effectively record, maintain, interpret and communicate data...
...additional support and assistance on tasks and projects as directed by management.
· Provide cover for Site Induction training and annual GMP Training.
· Working on Veeva Documentation Management System related activities in to build knowledge that will support the site
__...
...continuous improvement Projects in the Supply Chain and WH Areas.
Work with the quality system ensuring that the site quality policy and GMP and GDP is fully complied with on a continuous basis.
Contribute to the development of the Global Supply Chain Function, i.e. become...
...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...
...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.
~ Transferring and implementing processes,...
...science field related to the lab (e.g. Chemistry, Biochemistry, Pharmacy)
~5+ years of industry related experience in pharmaceuticals in a GMP lab
~Must have experience with mAbs
Additional Skills/Preferences:
~Demonstrated proficiency in complex laboratory analysis...
...continuous improvement projects in the engineering function.
Work with the quality system ensuring that the site quality policy and GMP and GDP is fully complied with on a continuous basis.
Contribute to the development of Global Engineering, i.e. become an active participant...
...Engineering or related subject with 2 years of experience in a quality or technical discipline
Familiarity with ISO 13485, QSR, GDP, GMP desirable.
Lean Six Sigma training a distinct advantage.
Working knowledge of Process Validation and Computer System validation...
...qualification studies.
Support and organize new instrument evaluation and purchase activities.
Produce and maintain accurate and GMP compliant records.
Support change control activities impacting QC equipment.
Perform impact assessments when required.
Perform...
...PowerPoint.
Stakeholder management of multi decision makers colleagues peers and cross functional teams.
Knowledge and experience of GMP and GDP in a pharmaceutical environment.
Desirable: Demonstrated knowledge in more than one pharmaceutical and/or chemical...
...experience in medium size manufacturing environment
~ Clean and Black Utility knowledge an advantage
~ Experience working within a GMP, clean room environment
~ LSS Certified (Desirable)
~ Excellent communication skills
~ Excellent problem-solving skills
Additional...
...and release of primary and secondary packaging components, QA review and approval of packaging and labelling documents, procedures, and GMP deviations for the client.
• Perform a wide variety of activities to ensure compliance with applicable cGxP regulatory requirements....
...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...
...Execute various maintenance tasks, including Corrective/Preventative/Production Support/Calibrations/Electrical work, adhering to site GMP (good manufacturing practices) and safety standards
Perform mechanical fitting tasks, focusing on the maintenance and repair of Mecatherm...
...people & equipment) and fulfilling costumer requirements.
Coordinate the implementation of new procedures.
Enforce fulfillment of the GMP and HSE policy, by supporting inspections and liaising with other Areas.
Plan and design manufacturing processes that ensure the...