On behalf of my client, I am recruiting for a Senior Professional – Quality Support. The successful candidate will work within the Quality Support Department, reporting to the Quality Support Manager. Key Responsibilities:
- Co-ordinate regulatory activities including site master file, licences, declarations, desk top audits and other regulatory support.
- Manage and participate in GMP inspections by partners and regulatory authorities.
- Actively support the development/implementation and continuous improvement of the Quality Management Systems on site.
- Co-ordinate and deliver quality management review and site quality council presentations, and act as project lead for onsite Quality initiatives.
- Manage/deliver site wide GMP Training Policy & Programmes, and mentor/train Quality Support Professionals.
- Assist in the preparation of reports in relation to Annual Product Quality Reviews.
- Liaise with other Department representatives to promote improvements in GMP and Quality standards.
- Support and deliver continuous improvements using problem solving tools including root cause analyses and CAPA identification.
- Support change control process as required, along with supporting the Review and Quality approval of documents as required.
- Third level qualification or higher in Chemistry/Pharmacy/Biology/Engineering or similar
- Minimum of 5 years relevant experience within quality or manufacturing function in the Pharmaceutical industry.
- SAP and Veeva Vault experience
- A strong understanding of pharmaceutical quality processes and systems, manufacturing processes and other support/control systems
- Demonstrated ability to work well as part of a team
- Excellent interpersonal and communication skills
- Demonstrated analytical ability, along with the ability to consistently drive for continuous improvement.
3 days ago
My client, a global CRO company based in Co. Mayo, is currently looking for a Senior Analytical Analyst to join their team. This role shall report to the Analytical Functional Manager and the main duties & responsibilities shall be:
- Project Management of routine batch release testing in the Analytical Services Department (client correspondence,/weekly calls, management of subcontractors, ensuring samples are released within the required timelines i.e. scheduling of tests, review of basic data, liaising with QA, generation of CoA etc.)
- Generation of GMP compliant SOPs, Protocols and reports.
- Sourcing, purchasing and stocking consumables, standards and reagents required for testing.
- Receipt and processing of test samples in LIMS
- Carry out data calculations, basic statistics and trending. Provide additional information at the clients request as required.
- Assist in internal, regulatory and client visits/audits and respond to findings.
- Carry out test method procedures like generic ELISA, MAT assay, microplate assays or client specific immunoassays.
- Safe and compliant disposal of all laboratory generated waste.
- A minimum of 2 years relevant experience in Scientific Research preferably within a GMP regulated environment (EMEA/FDA) within the Pharmaceutical, Medical Device, CRO Industry.
- Experience in project management essential.
- BSc/M.Sc. in a relevant science discipline (e.g. Analytical Chemistry)
- Experience in analytical techniques/immunoassays such as ELISA.
3 days ago
My client is a first-class pharmaceutical company based in Dublin. We are working with them on a new vacancy for a Country Study Manager. This is a fixed term contract. Reporting to the Head of Medical Expertise, the Country Study Manager (CSM) has specific responsibilities for clinical trials in Ireland. Purpose The Country Study Manager (CSM) provides leadership and local strategic planning and organization skills to ensure the effective and efficient delivery of operational aspects of one or more studies through all phases of study management (preparation, conduct, close-out), in accordance with the appropriate quality standards including ICH/GCP/GPP standards, SOPs, local operating guidelines and local requirements, as applicable. Key Tasks
- You will have full accountability and oversight for all assigned studies at regional/country level (Global and local studies) in accordance with the overall project plan, manages and maintains accurate country/study level plans (e.g. timelines, budget, resource, risk and quality plans) in the appropriate planning system.
- Highlights deviations and risks in plans to relevant parties, develops and implements mitigation strategies as required.
- Leads local study teams, represents Country/Region Clinical Operations at the global SMT, and provides Global Teams with feedback from an Affiliate perspective (Global).
- Plans and executes country study goals and commitments, and ensures compliance to relevant processes.
- May serve as global Country Study Representative (gCSR), as part of global study team.
- Coaches and provides support to responsible study team members.
- Provides study oversight, leadership and support to Contract Research Organisation (CRO) staff to ensure overall delivery at the country and site level, and interfaces with CRO Management regarding feedback on CRO staff performance as required.
- Oversees study feasibility, site monitoring performance, preparation of Risk Based Monitoring plans, and ensures eTMF completeness and oversight of all relevant compliance activities for allocated studies.
- Collaborates in local quality/compliance reviews, internal audits, and regulatory inspections, ensuring inspection readiness at all times and completion of Corrective and Preventative Actions for allocated studies.
- Develops and maintains optimal site relationships with key investigator sites, alliance partners and/or collaborative group for current and future studies.
- Participates in overall Therapeutic Area support together with the therapeutic leads and country experts (e.g. landscaping activities, investigator/site development activities or affiliate cross functional teams, etc.), as required.
- Take personal responsibility for maintaining high ethical standards and operating in compliance with local and global policies, the Group Code of Conduct, Quality Management System and the IPHA Code of Practice for the Pharmaceutical Industry.
- Science Degree or Nursing / Pharmacy qualification or equivalent.
- Leadership: developed through leading multi-functional matrix study teams through all stages of clinical studies
- Project Management: including implementation of risk management plans and management of complex study budgets and resourcing plans
- Communication: excellent written and verbal communication skills demonstrated by the ability to present clear messages from complex information/data to all levels in the organization
- Personal Organization: demonstrated ability to prioritize and manage multiple tasks, self-motivated and achievement driven.
- Good knowledge of ICH GCP, GPP, SOPs/Guidelines and quality standards related to study management.
- Clinical development experience on the operational aspects of conducting clinical studies including:
- Vendor/CRO resource management
- Leading/working as part of a development team implementing clinical development plans
- Risk management
- Coordinating study level activities to deliver data for filing or publication purposes including interaction with local Business Units
- Demonstrated ability to interact with different professional levels of the research community.
- Experience of influencing and negotiating at all levels to achieve team delivery
If you want to be part of a Global Team that develops your career please contact Tina at +353 1 2784671 or email your CV to [email protected]
Thornshaw Scientific is a division of the CPL group.
3 days ago
Role DescriptionOn behalf of our client, a global pharmaceutical company, we are actively recruiting for the role of Project QA for their Global Product Supply division. My client is in the process of creating a new quality project organization in Global Quality. This organisation will be responsible for all the GPS projects that are driven or supported by Global Quality. Roles & Responsibilities: You will work closely with the project organisation and stakeholders to ensure that quality standards are implemented in each initiated project, ensuring effective communication and alignment on deliverables and timeliness. Your primary responsibilities will be: Supporting SME /QA, representing Global Quality in GPS projects. Ensure that quality standards are implemented in projects Assure ongoing compliance with quality and industry regulatory requirements You will in a global team and be in contact with numerous people in multiple departments and functions. Qualifications & Experience required for this role: Relevant 3rd level qualification in science discipline Master degree preferred but not essential Certifications are an advantage including Quality Auditor, Quality Engineer, Quality Improvement Associate, Six Sigma, quality inspection, auditing and testing experience You should have several years of experience within the pharmaceutical industry and extensive experience with GxP/Quality. You are a self-starting and highly structured person who can get Quality on the agenda and deliver great results on time. Working cross-organisational takes effective communication and collaboration skills in combination with an open-minded and pragmatic approach that enables you to understand and respect different views and opinions. Excellent communication skills - verbal and written QA project experience Experience with implementation of corrective action programs For full spec and information email your CV to [email protected] or call Tina at +01 2784701
3 years ago