Team Horizon

4 job(s) at Team Horizon

Team Horizon City, Manchester
May 31, 2026
Contractor
Team Horizon is seeking a Validation Engineer for our client s Technical Operations team in the Northwest. This is a fixed term contract for 12 months and will report to the Validation Team Lead. This role is a fully on-site position in Ireland, are you willing to relocate? Do you have authorisation to work in the EU? Why you should apply: This role will provide you the opportunity to get exposure to a broad range of validation activities on site, and you You will be responsible for co-ordinating the development and maintenance of the company s validation program in compliance with all applicable regulatory and company requirements. What you will be doing: Co-ordinate, implement and participate in the site Validation Program. Ensure all computerised systems are qualified in compliance with Data Integrity policies and regulatory requirements. Co-ordinate / direction and participate in the validation of site equipment, facilities, utilities, processes and software in compliance with company policies, FDA, European cGMP and GAMP standards. Generate/maintain Validation Master Plans. Generate /maintain Project Validation Plans. Generate validation plans, write protocols and final reports to cGMP standard. Review / approve of protocols and final reports as required. Manage validation change control process. Adhere to and support all EHS & E standards, procedures and policies. What you need to apply: 3rd level qualification in a relevant engineering or scientific discipline. A minimum of 2 years experience in a cGMP regulated pharmaceutical manufacturing environment. High level of attention to detail and mental concentration, to ensure accuracy and compliance. Excellent communications skills with the ability to write protocols and reports. Proven problem-solving skills and the ability to adapt to new regulatory requirements. This role is a fully on-site position in Ireland, are you willing to relocate? Do you have authorisation to work in the EU?
Team Horizon
May 31, 2026
Full time
Team Horizon is seeking a Senior Product QA Manager & QP to join our client s team. This is a leadership role and is responsible for compliance with marketing authorisations, current Good Manufacturing Practices (GMP), and supporting New Product Introductions (NPIs). Relocate? This role is a fully on-site position in Ireland, are you willing to relocate? Do you have authorisation to work in the EU? Why you should apply: This is an excellent opportunity to make an impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience. What you will be doing: Manage QP , Regulatory, Change Management and New Product Introduction teams, including annual goal setting, performance reviews, development, and talent management. Ensure products (commercial and NPI/CTS) are manufactured and released in line with marketing authorisation, GMP, and company quality systems. Lead batch review and release, documentation, checks, and test completion. Oversee validation of manufacturing and testing processes and accurate record keeping. Provide quality governance on deviations, planned changes, and exception reporting with proper authorisations and regulatory notifications. Support NPI activities: change plan review, validation, documentation approval, and release of CTS batches Execute regulatory requests and submissions, engage directly with regulatory agencies (FDA, HPRA). Chair Change Review Boards, approve changes, oversee completion of QA tasks. Conduct internal/external audits and participate in regulatory/customer inspections. Manage complaint investigations, coordinate product recalls, and address quality defects. Ensure compliance with FDA CFR Parts 210/211/Q7, EU GMPs (ICH Q7, Volume 4), and QA Policies. Review and approve Product Quality Reviews (PQRs) and track finished product data. Provide QP oversight for SAP, LIMS setup changes, and manage site quality metrics. Act as Designee for the Quality Director when required. Lead department/site goals, provide technical leadership/guidance on QP/regulatory matters, and present technical data for decision-making. What you need to apply: MSc in Industrial Pharmaceutical Science (or a comparable course recognized for QP status per Article 49 of Directive 2001/83/EC). Minimum 10 years' experience in the healthcare/pharma sector within FDA/EMA approved environments. Demonstrated experience leading teams, with 7+ years in leadership roles Demonstrated attention to detail, strong problem-solving and innovative thinking abilities. Results-driven mindset with proven prioritization skills and commitment to quality. High integrity, strong work ethic, excellent verbal/written communication, and interpersonal skills. Relocate? This role is a fully on-site position in Ireland, are you willing to relocate? Do you have authorisation to work in the EU?
Team Horizon City, Manchester
May 31, 2026
Full time
Team Horizon is seeking a Senior Product QA Manager & QP to join our client s team. This is a leadership role and is responsible for compliance with marketing authorisations, current Good Manufacturing Practices (GMP), and supporting New Product Introductions (NPIs). Relocate? This role is a fully on-site position in Ireland, are you willing to relocate? Do you have authorisation to work in the EU? Why you should apply: This is an excellent opportunity to make an impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience. What you will be doing: Manage QP , Regulatory, Change Management and New Product Introduction teams, including annual goal setting, performance reviews, development, and talent management. Ensure products (commercial and NPI/CTS) are manufactured and released in line with marketing authorisation, GMP, and company quality systems. Lead batch review and release, documentation, checks, and test completion. Oversee validation of manufacturing and testing processes and accurate record keeping. Provide quality governance on deviations, planned changes, and exception reporting with proper authorisations and regulatory notifications. Support NPI activities: change plan review, validation, documentation approval, and release of CTS batches Execute regulatory requests and submissions, engage directly with regulatory agencies (FDA, HPRA). Chair Change Review Boards, approve changes, oversee completion of QA tasks. Conduct internal/external audits and participate in regulatory/customer inspections. Manage complaint investigations, coordinate product recalls, and address quality defects. Ensure compliance with FDA CFR Parts 210/211/Q7, EU GMPs (ICH Q7, Volume 4), and QA Policies. Review and approve Product Quality Reviews (PQRs) and track finished product data. Provide QP oversight for SAP, LIMS setup changes, and manage site quality metrics. Act as Designee for the Quality Director when required. Lead department/site goals, provide technical leadership/guidance on QP/regulatory matters, and present technical data for decision-making. What you need to apply: MSc in Industrial Pharmaceutical Science (or a comparable course recognized for QP status per Article 49 of Directive 2001/83/EC). Minimum 10 years' experience in the healthcare/pharma sector within FDA/EMA approved environments. Demonstrated experience leading teams, with 7+ years in leadership roles Demonstrated attention to detail, strong problem-solving and innovative thinking abilities. Results-driven mindset with proven prioritization skills and commitment to quality. High integrity, strong work ethic, excellent verbal/written communication, and interpersonal skills. Relocate? This role is a fully on-site position in Ireland, are you willing to relocate? Do you have authorisation to work in the EU?
Team Horizon
May 19, 2026
Contractor
Team Horizon is seeking a Validation Engineer for our client s Technical Operations team in the Northwest. This is a fixed term contract for 12 months and will report to the Validation Team Lead. This role is a fully on-site position in Ireland, are you willing to relocate? Do you have authorisation to work in the EU? Why you should apply: This role will provide you the opportunity to get exposure to a broad range of validation activities on site, and you You will be responsible for co-ordinating the development and maintenance of the company s validation program in compliance with all applicable regulatory and company requirements. What you will be doing: Co-ordinate, implement and participate in the site Validation Program. Ensure all computerised systems are qualified in compliance with Data Integrity policies and regulatory requirements. Co-ordinate / direction and participate in the validation of site equipment, facilities, utilities, processes and software in compliance with company policies, FDA, European cGMP and GAMP standards. Generate/maintain Validation Master Plans. Generate /maintain Project Validation Plans. Generate validation plans, write protocols and final reports to cGMP standard. Review / approve of protocols and final reports as required. Manage validation change control process. Adhere to and support all EHS & E standards, procedures and policies. What you need to apply: 3rd level qualification in a relevant engineering or scientific discipline. A minimum of 2 years experience in a cGMP regulated pharmaceutical manufacturing environment. High level of attention to detail and mental concentration, to ensure accuracy and compliance. Excellent communications skills with the ability to write protocols and reports. Proven problem-solving skills and the ability to adapt to new regulatory requirements. This role is a fully on-site position in Ireland, are you willing to relocate? Do you have authorisation to work in the EU?