...Requirements:
~ A third level qualification in an appropriate discipline is desirable.
~4-5 years’ Experience within a regulated GMP environment is desirable
~1 year plus experience in the day-to-day operation of the quality system in a highly regulated combination...
...leading Life Sciences company located in the North West of Ireland . The QA Specialist ensures product manufacturing complies with GMP and Regulatory standards. Responsibilities include validating facility, equipment, and utilities, as well as reviewing and approving...
...Operating Procedures.
Qualifications
Third level education in a relevant Science / Engineering course or 2 year's experience in GMP manufacturing is essential
Desired: Three years plus of Knowledge of cGMP and regulatory requirements relating to the pharma/...
...automation discipline, with a minimum of 10 years’ experience in industry, preferably in a pharmaceutical, biotechnology, blue chip or relevant GMP manufacturing environment. The ideal candidate will have excellent communication & problem solving skills as well as strong stakeholder...
...experience of over 3 years Commissioning Qualification in a project environment.
Experience in regulatory and industry standards for GMP, cGMP and GDP
Excellent technical writing skills including deviation reports and validation reports.
Pharmaceutical (oral solid dose...
...you will be doing:
· Delivery of process systems and vendor packages
· Working as part of a large CAPEX Projects team within a start-up GMP facility (greenfield / brownfield).
· Involvement in design, Vendor review, FAT, SAT, I/O/PQ
· Work with project stakeholder team to...
...execution of manufacturing activities .
Responsibilities (Full job description available on request):
Assist in maintaining a safe, GMP compliant work environment at all times.
Become competent and trained on all unit operations including tableting, blistering,...
...experience. You should ideally have at least 1 years of experience of Validation activities for equipment found in Pharmaceutical or other GMP regulated environments. Some experience of the Validation of aseptic processes would be essential.
The ideal candidate will have...
...In this role you will need;
~3rd level qualification, preferably in Engineering or Science related fields OR 2+ years in a GMP regulated environment
~ Experience of operating in a highly automated environment
~ safe handling of dangerous chemicals is desirable...
...management.
• To provide training – cross training, multi-skilling, job-rotation.
• To conduct recruitment and induction.
• Ensure GMP (Good Manufacturing Practices) requirements are maintained.
• Production planning to meet customer demands.
• To guide others to...
...issues, in compliance with site CA/PA system requirements.
To participate in BEx projects as a team member.
To adhere to all GLP and GMP requirements and ensure safety standards are met and safe working practices are adhered to.
Requirements:
A third level...
...demonstrated competence.
4+ years of experience in an automation engineering role with at least 2 years of this in Good Manufacturing Practice (GMP) environments (Life Sciences, Pharma, Medical Devices).
Based in the Sligo area or within a reasonable commute and able to be onsite...
...required or equivalent science discipline.
A good knowledge of aseptic processes' manipulation together with experience within a GLP/GMP environment and knowledge of current EU/FDA/ICH/HPRA guidelines.
Lab experience within industry - Bioburden / Endotoxin / Growth...
€50k - €60k per annum
...Reports to: Quality Manager
Job Purpose: As a QA Specialist, you will play a crucial role in ensuring product quality in compliance with GMP and Regulatory requirements. This individual contributor position requires a self-starter with expertise in QA and validation...
...careful handling of all inventory materials to avoid Distressed Inventory.
Ensure Location System is maintained as required.
Ensure GMP requirements are maintained.
Complete regular checks to verify that processes including, material segregation, labelling and storage...
...Minimum of a Level 7 qualification in a science or engineering discipline.
A level 6 with a minimum of 3 years’ experience in a GMP Manufacturing requirement shall be deemed equivalent.
Interested candidates should submit an updated CV.
Please click the link below...
...problems, effect changes in procedures and ramp up line speeds or throughput.
Ensure strict compliance with all procedures, regulatory and GMP requirements, quality procedures including record keeping, inspection standards, product disposition and validation protocols....
...required or equivalent science discipline.
A good knowledge of aseptic processes' manipulation together with experience within a GLP/GMP environment and knowledge of current EU/FDA/ICH/HPRA guidelines.
Lab experience within industry - Bioburden / Endotoxin / Growth...
...science, quality or engineering discipline.
A minimum of three years’ experience in a quality/operations role in a highly regulated GMP environment. Experience in biologics manufacturing is highly desirable.
Experience in aseptic processing gained within either a quality...
...process plant.
· Ensure the maintenance of appropriate test instrumentation.
· Ensure the maintenance of pest control, housekeeping and GMP.
· Ensure prompt attention of the Manufacturing Manager in areas of risk, which might have an adverse effect on product quality and/...
...suppliers W.I.P and finished products ensuring achievement of plant inventory level goals.
Maintain high standard in housekeeping, GMP and Safety.
Contingency Planning when have technical or supply issues.
Execute to the production schedule by ensuring Process Orders...
€ 15.44 - 16.06 per hour
...which conforms to the requirements of the Medical quality system, paying particular attention to the required standards of housekeeping, GMP and safety.
Maintain product, packaging, raw material and component accountability and traceability, labelling, product and...