Regulatory Compliance Expertise Lead
7 days ago
Job Summary: We are seeking an experienced Change Control Topic Lead to join our team, who will be responsible for leading and maintaining the change control business system, providing oversight and guidance on change requests, and mentoring site users of change control systems.
The successful candidate will have a strong understanding of quality policies and procedures, cGMP and manufacturing policies & procedures, and will be able to provide input and guidance on change requests.
Key Responsibilities- Owner and Chair of the Site Change Collaboration Meeting
- Attend Supplier Change Evaluation Meetings
- Attend Tier 3 Meetings to Discuss Endorsements for All Change Requests with Potential Regulatory Impact
To be successful in this role, you will need:
- A 3rd-level qualification in a Science or Engineering discipline or a related field
- 5+ years of experience in a related discipline
- Strong communication skills, both oral and written
- Project management skills
- Decision-making and problem-solving skills
- Leadership principles
- Quality policies and procedures
- cGMP and manufacturing policies & procedures
- Teamwork skills and ability to work across boundaries
-
Regulatory Compliance Expert
6 days ago
Ballydine Cross Roads, County Tipperary, Ireland Merck Gruppe - MSD Sharp & Dohme Full timeMERCK GRUPPE - MSD SHARP & DOHME is dedicated to 'Inventing for Life' in all that we do. As a Regulatory Compliance Expert, you will be responsible for ensuring that our products and processes meet regulatory requirements.Your key responsibilities will include:Reviewing and approving production and analytical documentation to ensure conformance to GMP and...
-
Quality Assurance Specialist
6 days ago
Ballydine Cross Roads, County Tipperary, Ireland Merck Gruppe - MSD Sharp & Dohme Full timeAt Merck Gruppe - MSD Sharp & Dohme, we are committed to 'Inventing for Life' in all that we do. As a Quality Assurance Specialist, you will be responsible for ensuring the quality of our products and processes.Your key responsibilities will include:Reviewing and approving production and analytical documentation to ensure conformance to GMP and regulatory...
-
GMP Auditor
6 days ago
Ballydine Cross Roads, County Tipperary, Ireland Merck Gruppe - MSD Sharp & Dohme Full timeWe are seeking a highly skilled GMP Auditor to join our team at MERCK GRUPPE - MSD SHARP & DOHME. As a GMP Auditor, you will play a critical role in ensuring the quality of our products and processes.Your key responsibilities will include:Reviewing and approving production and analytical documentation to ensure conformance to GMP and regulatory...
-
QA Analyst
6 days ago
Ballydine Cross Roads, County Tipperary, Ireland Merck Gruppe - MSD Sharp & Dohme Full timeWe are seeking a highly skilled QA Analyst to join our team at Merck Gruppe - MSD Sharp & Dohme. As a QA Analyst, you will play a critical role in ensuring the quality of our products and processes.Your key responsibilities will include:Reviewing and approving production and analytical documentation to ensure conformance to GMP and regulatory...
-
Senior Process Development Engineer
1 week ago
Ballydine Cross Roads, County Tipperary, Ireland MSD Full timeJob DescriptionA fantastic opportunity has arisen for a Senior Process Development Engineer.You will be a key contributor and site lead of a new product introduction or technical transfer to and from the site, including new technologies.You will work as part of a multi-functional, diverse team to deliver results within schedule and product launch milestones....
-
Senior Process Development Engineer
3 days ago
Ballydine Cross Roads, County Tipperary, Ireland MSD Ireland Full timeJob DescriptionA fantastic opportunity has arisen for a Senior Process Development Engineer.You will be a key contributor and site lead of a new product introduction or technical transfer to and from the site, including new technologies.You will work as part of a multi-functional, diverse team to deliver results within schedule and product launch milestones....
-
Spclst, Quality Assurance
6 days ago
Ballydine Cross Roads, County Tipperary, Ireland Merck Gruppe - MSD Sharp & Dohme Full timeJob DescriptionAn amazing opportunity has arisen for a Spclst, Quality Assurance.What you will do:Review and approve production and analytical documentation accompanying the release of drug substance, drug product and packaged finished goods to ensure conformance to appropriate SOPs, GMP and regulatory requirements, including supporting QP...
-
Change Control Topic Lead
7 days ago
Ballydine Cross Roads, County Tipperary, Ireland MSD Full timeJob DescriptionAn amazing opportunity has arisen for a Change Control Topic Lead.What You Will DoBring energy, knowledge, innovation and leadership to carry out the following:Lead and maintain the change control business system (as Site Topic Lead for QMS Topic 3.4).Initiation, ownership and management of changes as required. Changes may be related to...
-
Financial Planning Business Partner
4 days ago
Ballydine Cross Roads, County Tipperary, Ireland MSD Ireland Full timeKey ResponsibilitiesDevelop and implement internal financial controls and procedures to ensure compliance with regulatory requirements and company policies.Lead the preparation of R&D Tax Credits submissions and Government Grants claims to optimize tax benefits and minimize costs.Contribute to site management operational and strategic initiatives, such as...
-
Scientist, Chemistry
2 weeks ago
Ballydine Cross Roads, County Tipperary, Ireland Merck Gruppe - MSD Sharp & Dohme Full timeJob DescriptionAn amazing opportunity has arisen for a Scientist within the High Potency Laboratory facility.What you will do:Bring energy, knowledge, innovation and leadership to carry out the following:Leading the generation of SOP's and laboratory practices for High Potency Laboratory.Testing of high potent samples in accordance with approved methods and...
-
DeltaV Automation Engineer
2 days ago
Ballydine Cross Roads, County Tipperary, Ireland MSD Ireland Full timeJob DescriptionAn amazing opportunity has arisen for a DeltaV Automation Engineer supporting the first DeltaV installation at site.What You Will DoBring energy, knowledge, innovation and leadership to carry out the following:Providing day to day support to operations for our new DeltaV API facility.Supporting capital projects to ensure DeltaV DCS automation...
-
Sr. Spclst, Fin. Planning
4 days ago
Ballydine Cross Roads, County Tipperary, Ireland MSD Ireland Full timeJob DescriptionA fantastic opportunity has arisen for a Senior Specialist, Financial Planning & Analysis (Temp).Our Finance team brings together our financial perspectives into our overall strategic and tactical decision making. We use state-of-the-art techniques for financial analysis, planning, accounting, reporting and performance evaluation. This allows...
-
QC Technician
2 weeks ago
Brownstown Cross Roads, Co Kildare, Ireland Kilsaran Full timeTechnical - Brownstown, Kilcullen, Co.KildareAs Irelands leading manufacture of building materials, Kilsaran see's itself at the forefront of innovation and sustainable practices. We are seeking a Quality Laboratory Technician for our KPRO dry mortar laboratory, to assist in all aspects of our documented Quality Control and Quality Assurance test...
-
Clinical Support Specialist
6 hours ago
Northern Cross, Ireland Uniphar Medtech Full timeRole OverviewThe primary focus of this role is to provide exceptional support to customers implementing new equipment solutions in healthcare settings throughout Ireland. As a Clinical Support Specialist, you will be responsible for delivering comprehensive training and service support to customers and colleagues across Cardiac Services.Key...
-
Hospital Sales Specialist
1 day ago
Northern Cross, Ireland Uniphar Medtech Full timeThe Hospital Sales Specialist will achieve sales and market share objectives by selling and demonstrating our range of medical devices, associated consumables and digital solutions to a large customer base of hospitals within Ireland.This role will primarily be responsible for account management of existing customer base and business development of new...
-
Clinical Applications Specialist
10 hours ago
Northern Cross, Ireland Uniphar Medtech Full time*Purpose of Role:*The primary focus of the role is to support customers implementing new equipment solutions in healthcare settings throughout the island of Ireland. The successful candidate will be responsible for providing exceptional training and service support to customers and colleagues across Cardiac Services. They will also provide clinical insight...
-
Project Engineer
4 weeks ago
ballydine, the borough district of clonmel, ireland Asset Recruitment Full timeref. 01237Project EngineerJoin our client's dynamic Site Projects Group as a Project Engineer and support site Capital & Expense projects in a Pharmaceutical facility in Ballydine. Reporting to the Site Projects Lead, you will play a key role in driving project success within the site portfolio of projects. We are seeking a passionate individual with the...
-
Instrument Specialist
4 weeks ago
ballydine, the borough district of clonmel, ireland MSD Ireland Full timeJob DescriptionAn amazing opportunity has arisen for a Laboratory based Instrument Specialist. The position reports to the Laboratory Systems Lead.The position offers the opportunity to work with a team of professionals in a modern analytical laboratory using the most up to date technology and quality assurance procedures. The laboratory operates under Lean...