Job description

Quality Assurance Specialist

About Your New Employer

My client is a leading light in the medical technology, care solutions and intelligent devices industries. The goal of the company overall is to build a world where healthcare has no limits.

About Your New Job

• You must coordinate QA compliance systems, such as IR/CAPA, change control, customer complaints, vendor management, GMP documentation, internal audits, global standards & policies, GMP training, technical agreements, regulatory submissions, site Master File/Manufacturing licences and PQRs.
• You must provide support to plants regarding resolution & approval of compliance issues/actions (IRs/CAPAs} & participate in cross-functional teams involved in investigating & supporting resolution of issues Approve site GMP documentation (validation protocols/reports, analytical reports, SOPs).
• You must conduct QA activities such as preparation/revision of SOPs & training modules and training personnel.
• You must support local processes to embed & maintain global policies, standards, procedures & best practices.
• You must support batch release processes, packaging batch records and production reviews.
• You must participate in the site inspection readiness programme & the internal auditing function as appropriate.
• You must participate in the organisation of compliance audits from external regulatory bodies.
• You must support the development and maintenance of Quality System metrics & support local QA leadership team regarding preparation and execution of Quality Management Reviews
• You will represent the QA on development projects and process involvement initiatives.
• You must support team members & perform other activities in the areas of GMP compliance when required.
• You must support the platform (Packaging/Production) structure in the areas of GMP compliance when required.

What Skills You Need

• 3 - 5 years of industry experience (preferably pharmaceutical experience) is a must.
• A minimum of a level 8 in a science or engineering discipline.
• You must have excellent team working skills
• You must have excellent problem-solving skills.

What’s Next

Apply now by clicking the “Apply Now" button or call me, Dominic King on +353 91 455309 or email: dking@sigmar.ie

Or if the job isn’t quite right but you are looking for something similar, please get in touch. We also have multiple Temp, FTC and Contract jobs available.

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