Medical Device Regulatory jobs

Company Overview:

A role has arisen to join a small Pharmaceutical Consultancy Firm based in the South East as a Pharma Quality & Regulatory Officer. The Company has contracts with national and international global pharmaceutical manufacturing and distribution companies in Ireland and the UK.

(Office based in South Kilkenny, 10 minutes from Waterford)

This is an exciting opportunity to join a well-established and growing Pharmaceutical Consultancy company. Covering a variety of areas this candidate has the opportunity to gain knowledge and exposure to many different departments. A fantastic opportunity to work alongside a highly skilled and knowledgeable workforce. For the right candidate there is the potential for future opportunities and to grow with the company.

Full on the job training will be provided.

Duties:

• Implementation of quality systems for manufacturers, distributors and marketing authorisation holders in line with EU GMP/GDP requirements.
• Print, prepare, review batch documentation prior to QP review.
• Compile and review quality documentation (SOPs, Protocols, reports, validation master plans, training modules etc) for GMP and GDP systems.
• Review of regulatory documents prior to submissions
• Aid with deviation investigation, risk assessments and change controls.
• Prepare and/or review temperature mapping protocols and reports.
• Project work for Pharmaceutical and Storage companies.
• Auditing and other project work
• Administration work.
• Support marketing department with marketing materiel reviews and preparation.

Experience

• 1 -2 years’ experience required in pharma/medical device, wholesale, manufacturing or related industry.
• Experience in Regulatory Affairs, Qualified Person (QP), or Responsible Person (RP)/Deputy Responsible Person (dRP) roles would be an advantage but is not essential.
• Great advantage to have experience in Batch reviews or SOP writing.
• Excellent PC skills and administration skills (OFFICE)

Core Skills and Specifications:

• Minimum diploma level education (science or engineering discipline)
• 1 -2 years’ experience required in pharma/medical device, wholesale, manufacturing or related industry.
• Solid understanding of regulatory affairs principles, applicable regulations, and guidance documents.
• Strong attention to detail, organizational skills, and ability to manage multiple priorities.
• Must be reliable and well organised with excellent oral and written skills.
• Good teamwork and strong issue resolution and communication skills across functions and organisations.
• An ability to work flexibly in a changing environment. Good attention to detail and priority management essential.
• Flexibility to learn new skills and take on new tasks and responsibilities.
• The ability to work independently.
• Highly Self-Motivated, Interested in Career progression
• Good Attention to detail
• Multi-tasker

Package:

Contract length: 11 months, with the possibility of a permanent position.

Role is full-time.

Salary: DOE

Benefits:

• Flexible working environment
• Hybrid & Remote Working
• Flexitime
• On-site parking
• Work from home

Job Type: Full-time

Benefits:

• Bike to work scheme
• Flexitime
• On-site parking
• Work from home

Experience:

• pharmaceutical manufacturing or wholesale / pharmacist: 2 years (preferred)

Work Location: Hybrid remote in Mullinavat, County Kilkenny