HiTech Health focuses on enabling healthcare companies to launch and support products. The company was established in 2013 in Dublin, Ireland, bringing together an experienced and multi-disciplinary team from across the pharmaceutical, biotechnology and medical device industries. Operating internationally, HiTech Health supports healthcare companies from the development to the launch and supply of products.
HiTech Health are now recruiting for the position of Qualified Person. This is an exciting role for a dynamic individual to join a growing organisation, to work with a number of clients and contribute to a variety of projects.
The role involves supporting Quality Assurance activities for HiTech Health as a service provider to clients. The candidate will play a key role in the development of the company. The ideal candidate will be responsible for ensuring quality compliance with U.S. and E.U. requirements from early development right through to commercial manufacturing and supply to patients.
Please see the following link for more information; http://hitech-health.com/qualified-person/
The TCP Group is a healthcare service provider, specialising in ‘direct to patient services’ which include the dispensing and distribution of pharmaceutical products, homecare nursing services and sharps waste management, facilitating a unique turnkey solution for the delivery of hospital care in the patient’s home.
TCP Homecare is currently recruiting for a Quality Manager position based in their Head Office in Dublin. The role of the Quality Manager/Responsible Person will be to develop and maintain a QMS whilst meeting the requirements of regulatory and quality standards for GDP/PSI/Nursing services. For further information, see the job description TCP Quality Manager position.
Posted 5th June 2019
GSK are recruiting for a number of quality roles based at their Citywest office.
Two of the roles are LOC (Market Affiliate) Quality roles:QA Manager (WD206231) and Quality Executive (WD206232) will act as RP and Deputy RP on the GlaxoSmithKline (Ireland) Ltd. WDA and manage/support all MAH GxP activities.
The third role is a Quality Specialist role (WD204069), supporting the new Trading Partners Quality function based in Dublin.
Previous GDP experience desirable.
Applications to be made via GSK Job portal https://ie.gsk.com/ie/careers/search-jobs-and-apply/ and search for the Job ID as above.
Posted 26th April 2019
The Baxter Healthcare Ltd Compounding Facility in Dublin operates to a Manufacturing Authorization awarded by the Health Products Regulatory Authority (HPRA). Sterile batch and patient specific products are manufactured using isolator technology in a clean room environment. Baxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-centre dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition.
Baxter Healthcare are currently recruiting for both a Quality Specialist and a Quality Batch Releaser at their Deansgrange site.
For more details on these roles, visit https://jobs.baxter.com/ListJobs/All/Search/Job-Country/Ireland/?lang=en
Recordati Ireland have a vacany for a Regulatory Affairs Manager. This role involves the regulatory management of Recordati Corporate products all over the world, in strict cooperation with the International Pharma Sales Team at Recordati Ireland and with the International Regulatory Affairs team at the HQ in Milan, Italy. Recordati Ireland is responsible for over 1000 marketing authorizations in over 100 Countries.
See job description Recordati Ireland Reg Affairs Manager role.
Posted 14th Dec 2018
MSD Ballydine are currently recruiting for a Quality Specialist role which may be of interest to recently qualified pharmacists.
MSD Ballydine develops and supplies the active ingredients and final formulated product for a range of innovative medicines at its manufacturing and R&D facilities. The plant, which has been operating in Tipperary for over 40 years, exports to over 25 countries around the world with primary markets being Europe, USA and Japan.
For further information, see MSD Ballydine Quality Specialist role.
Posted 30th Nov 2018
IQVIA (formerly Quintiles) are recruting for a number of positions in their Dublin office (Eastpoint Business Park):
If you have any questions about the above vacancies, please feel free to contact Lana Wills – Lana.Wills@quintiles.com.
Posted 19th Nov 2018
MSD Ballydine are currently recruiting for a Technical Process Engineer position which may be of interest to pharmacists with an interest and some experience in a technical manufacturing role. MSD Ballydine develops and supplies the active ingredients and final formulated product for a range of innovative medicines at its manufacturing and R&D facilities. The plant, which has been operating in Tipperary for over 40 years, exports to over 25 countries around the world with primary markets being Europe, USA and Japan.
For further information, see MSD Ballydine Technical Process Engineer role.
Posted 15th Nov 2018
Paraxel are currently recruiting for Consultants in their Kilmainham Dublin office. The website link is https://jobs.parexel.com/job/dublin/regulatory-affairs-consultant/877/9246740.
CMC Consultant Overview:
A Consultant must have an understanding of the organization’s consulting models and methodologies, as well as, good knowledge of what services PC provides.
A consultant must have strong technical skills and may be developing specialist knowledge of a particular subject and/ or market.
A consultant ensures the timely performance of work within a project scope to the quality expectations of PC and the client. When serving as a Project Technical Lead, a Consultant assures the work of the entire team is delivered on time and that it meets client’s and PC’s quality expectations.
-Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline, Advanced Degree Preferred
-Several years of experience in an industry-related environment
-Variation/Lifecycle Maintenance experience EU/RoW: Simple (Type I), complex variations (Type II) to EU markets in the CP and NP procedures, Renewals etc.
-Change Control assessment experience
-Capable of participating in discussion on regulatory strategies with a wide stakeholder network (QA, Brand Leads etc.) with support of an SME
-Proactive’ and ‘efficient working method
-Strict adherence to timelines (both internal and HA deadlines)
-Excellent interpersonal and intercultural communication skills, both written and verbal
-Client-focused approach to work (Quality)
-Teamwork and collaboration skills
-Critical thinking and problem-solving skills
-Proficiency in local language and extensive working knowledge of the English language
Posted 25th Oct 2018