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
EirGen Pharma in Waterford (part of OPKO, Miami, US) are recruiting a number of Science graduates to join their Regulatory/Clinical Affairs team with immediate start. The Regulatory department has a structured training program for graduates delivered by both internal and external trainers with extensive experience of Global Regulatory Affairs. This is an exciting opportunity to join an expanding Regulatory Affairs department supporting EirGen's newly built R&D facility in the space of New Drug Development and niche Generic drug development in a variety of dosage forms, including Oral Solid Dose – immediate and modified release, soft capsules and liquid fill hard capsules and Fill/Finish for both small molecules and biologics. See job description for further information EirGen Reg Affairs Office positions_Aug 2018.
For anyone who wishes to apply they can send a copy of their CV to HR@Eirgen.com.
Posted 19th Oct 2018
The HPRA are currently recruiting for a Pharmaceutical Assessor, in the Pharmaceutical Assessment – Human Products Authorisation and Registration Unit. Would be an ideal position for a pharmacist with some industry experience.
Irish Medicines Verification Organisation (IMVO) are looking for an experienced quality professional for the role of Quality Manager. This will be a part-time (0.5 FTE) position, based in Dublin. For further information, please see the role profile IMVO Quality Manager (part-time).
To apply or to make an informal enquiry, please contact Leonie Clarke, IMVO Project Manager (email firstname.lastname@example.org).