Main purpose of job: Perform analytical testing in an efficient and effective manner under cGMP guidelines. Take a lead role in method transfer activities collaborating with other PCI Pharma sites. Actively participate in new departmental training and adhere to company policy/procedures and pertinent regulatory/company requirements. Main responsibilities: […]
Main purpose of job: Manage the activities associated with the environment, health, and safety (EHS) performance, and assurance, for operations. Provide oversight, advice, and governance of EHS capabilities, activities, and performance for the Site. Main responsibilities: * To deliver compliance and professional advice in the application […]
Profile Hands on engineer with ability to maximize machine reliability and throughput while supporting new projects. Ability to synthesise information from various sources and analyse and decide on a course of action. Primary Responsibilities * Directly responsible for taking action on machines to ensure that yield and […]
Responsibilities: * Responsible, in conjunction with the immediate supervisor for shift output, quality and yield in compliance with the requirements of current Good Manufacturing Practice. * Ensure that all product produced conforms to the approved specification: * Visual inspections are carried out at […]
Responsible, in conjunction with the immediate supervisor for shift output, quality and yield in compliance with the requirements of current Good Manufacturing Practice. Main responsibilities: * Ensure that all product produced conforms to the approved specification; * Visual inspections are carried out at […]
The supervisor role will involve the Management of People and Processes, providing strong, capable leadership and clear direction and guidance to all team members to ensure that customer expectations are met and delivered on time. This role is essential to our overall corporate objective--to ensure that the production processes results […]
Main purpose of job: The role is to implement and execute tasks relating to QP duties and certification activities associated with manufacturing processes/activities performed under PCI Ireland IMP, MIA and veterinary licences. This role is a Senior QP role and will take a lead role in PCI Ireland QP […]
Main purpose of job: The purpose of this role is to put in place and manage the PCI Ireland laboratory. Aspects such as building procedures, purchasing equipment and people management, pricing, strategy for QC growth are all in scope for the role. The role also includes cleaning validation lead […]
The role is to implement and execute tasks relating to day to day Operational Quality aspects. The role entails taking responsibility for Quality matters around process and documentation. The role also acts as the key point of contact with customers in relation to quality issues. ESSENTIAL DUTIES […]
* Writing and reviewing SOP's, Work Instructions and Forms. * Coordinate and Review Deviations, Non-Conformance reports, Corrective and Preventive Action Requests and assist in the preparation of final reports for QP review. * Coordinate the Change Control Board, follow up on change control […]
* To perform routine laboratory procedures right first time with minimal personal OOS results. * To assist in the planning and prioritising of own day to day workload in line with client requirements and adapt this where necessary in line with client needs and expectations. […]
To perform analytical data review and data interpretation activities in an efficient and effective manner in full compliance with relevant documented procedures and pertinent regulatory/company requirements for Analytical Development. * To perform Analytical Development laboratory data review and interpretation in support of ongoing method development, method validation, in process testing, […]
* To perform routine laboratory procedures right first time with minimal personal OOS results. * To assist in the planning and prioritising of own day to day workload in line with client requirements and adapt this where necessary in line with client needs and expectations. […]
To perform the Analytical testing function in an efficient and effective manner in full compliance with relevant documented procedures and pertinent regulatory/company requirements. * To perform routine laboratory procedures right first time with minimal personal OOS results and if relevant and instructed to do so, to assist […]
Provide a packaging & artwork development service for PCI Pharma in line with business needs, this includes, but is not limited to: packaging materials and specifications, design of appropriate packaging, origination, control and approval of artwork to meet both internal and client requirements. In addition, creation of Serialisation labels and […]
Main Responsibilities: * To follow labelling and assembly instructions in line with company requirements and external regulations. * To complete assembly documentation in line with company requirements and external regulations. * To maintain the cleanliness of the packing rooms * To […]
Main Responsibilities: * Provide continuous support to Project Manager and team by being the daily point contact for day-to-day internal problem solving and trouble-shooting. * Leads weekly customer calls and CPT meetings in absence of Project Manager. * Creates notes for weekly customer […]
Documentation support and technical support for the on-boarding of new manufactured products to the business. Support for achieving of project milestones and support for technical issues and investigations including support for improvement projects. * Responsible for the creation of manufacturing batch records (BMR) for product development, technical transfer […]
Main Responsibilities: * Collaborates with Subject Matter Experts (SME) to gather supporting information to be captured within proposals. * Reviews clinical trial strategies presented within Request-for-Quote (RFQ) and calculates quantities of materials needed for production. * Assigns costs within proposals based on services quoted. […]
* Forecast clinical supply demand and manage clinical supply inventory throughout the clinical trial globally. * Adjust re-supply strategies by assessing clinical protocol revisions and analysing enrolment rates, inventory usage, and trends. * Utilize simulation tools and supply chain expertise to determine packaging […]
To write high quality technical analytical documentation and to perform analytical data review and data interpretation activities in an efficient and effective manner, in full compliance with relevant documented procedures and pertinent regulatory/company requirements to generate trending and PQR data for Analytical Services. * To perform […]
General Purpose of Role: Manages assigned clinical customer projects to ensure that project goals and objectives are accomplished within the prescribed time frame, budget, and in accordance with customer expectations. Fill role of Lead Project Manager for global clinical studies where required. Diligently manages significant matters pertaining to […]
Main purpose of role: To manage the activities associated with the environment, health and safety (EHS) performance, and assurance, for operations at the Hay-on-Wye Site. To provide oversight, advice and governance of EHS capabilities, activities and performance for all European Commercial Sites. To co-ordinate the Global Safety Team and leadership […]
The job holder will provide expert professional advice, coaching and support to managers and staff on all aspects of people management, which fully reflects the desire to be an employer of choice, current employment legislation and best practice. * Work closely with managers, providing them with expert […]
To work with the Internal Stakeholders to deliver an effective HR support system. To deliver Core HR services and support to the business * Advise and support on ER issues, including assisting with training in relation to conducting investigations, chairing hearings, listening to grievances etc. * […]
We require a proactive and diligent individual to join the Laboratory team at our Hay on Wye facility. You will demonstrate initiative, flexibility and have a positive attitude as well as being a strong team player. Main purpose of role To perform analysis of analytical samples in […]
Working under limited supervision to manufacture pharmaceutical products in compliance with GMP standards following Standard Operating Procedures and Health and Safety guidelines. * To dispense raw materials required for manufacturing as per written instructions using calibrated equipment. * To prepare bulk liquid solutions, […]
* Responsible for ensuring new projects are initiated into the organization in line with the formal introduction procedure and continually improving the onboarding processes * Responsible for the management and leadership of the project managers that report directly to them * Responsible for ensuring that support functions […]
General Purpose of Role: Raise Orders for dispatch, collection or logistics requirements on time and in accordance with standard procedures. Track shipments to ensure ontime delivery to maintain client satisfaction. Deal with Clients and Suppliers on a daily basis reporting any issues to the relevent PCI Bridgend personnel. Main […]
The job holder is required to work on their own initiative and largely independently on key responsibilities under the supervision of Senior Scientists or Pharmaceutical Development Managers. The role is responsible for timely work on all aspects of their assigned pharmaceutical development project or process/equipment train, including client and […]
Main purpose of role: You will operate machinery or hand pack as instructed to package pharmaceutical products ensuring that Good Manufacturing Practice (GMP), regulatory and safety standards are met. Main responsibilities: Safety * Compliance with safety and Personal Protective Equipment (PPE) requirements * […]
Hybrid/Remote working possible with this role Responsible for ensuring that all project deliverables meet client agreed milestones and that support functions are aligned to deliver on time if full under excellent client service. To forecast and report accurate financial performance of client accounts whilst driving organic growth of […]
To organise and provide QP certification for pharmaceutical products (commercial and investigational medicinal products), primarily those manufactured and assembled at PCI Pharmaceutical Services Limited, but may take responsibility for products manufactured elsewhere (i.e. third country imports on occasion). Responsible for QP certification of commercial and investigational medicinal products ensuring on-time, on-budget […]
* To control and issue relevant GxP documentation which ensures the timely release of product. * Contribute to ensure that all KPIs, targets and any other deadlines relevant to the role are met. * The nature of the role of Quality Document Controller requires consistency of attitude […]
* To ensure the effective administration, monitoring and completion of Quality System activities at PCI Tredegar. * The job holder is required to work on their own initiative and largely independently on key responsibilities under the supervision of the Senior Quality Specialist. * The […]
We have an exciting new permanent opportunity within our IT department. Main purpose of role: Senior level technical software support for all Global Enterprise Systems, with a major focus on PCI's ERP System J.D. Edwards (JDE). Senior role with taking on level 2 and level 3 service tickets from the […]
Main Responsibilities: · Oversee a team managing the execution of the Sales Order process, including but not limited to: o Accurate management of the Orders Inbox o On-time raising of Sales Orders o Preparation of all paperwork to support on-time despatch for EU and Non-EU […]
The role requires the individual to lead a small team of scientists and manage multiple complex pharmaceutical development, transfer and scale up projects. To provide technical expertise in pharmaceutical development, transfer and scale up over a range of dosage forms. To be client focussed and deliver projects to agreed timelines […]
* This role reports into the Team Leader within the Contained Manufacturing Facility (CMF) * The role requires staff to perform technical operational activities and ensure the cGMP compliant delivery, technical transfer and continuous improvement of Commercial and Clinical projects for internal and external clients […]
* To organise and manage all stability studies within the Analytical Services department. * To ensure compliance with relevant Company, local and international Regulatory and Client requirements at all times. * To ensure that stability time points and sample pulls comply […]
We have a new permanent opportunity to join our Warehouse night shift. Main purpose of role: To provide a good level of service to Production departments, whilst also maintaining high levels of cGMP in all warehouse environments. To ensure that all warehouse activities are carried out safely and to […]
STELLENAUSSCHREIBUNG:: Stelle: (Junior)Mitarbeiter Qualitätssicherung (m/w/d) Standort: Großbeeren bei Berlin Abteilung: Quality Assurance Vorgesetzter: Quality Assurance Manager Führungsverantwortung (für Mitarbeiter): N/A Die Rolle besteht darin, Aufgaben im Zusammenhang mit den täglichen Aspekten der Qualitätssicherung zu implementieren und auszuführen. Die Rolle beinhaltet die Übernahme von Verantwortung für Qualitätssicherungsangelegenheiten rund um QMS-Prozesse und Dokumentation. HAUPTAUFGABEN UND VERANTWORTLICHKEITEN: Verfassen, […]
Job Description: Job Title: Lead Generation Manager Location: Germany or UK or Ireland, Home Based Department: Business Development Clinical Services Work Pattern: Full-time Reporting to: Director Business Development Europe Responsible for (staff): N/A As a Lead Generation Manager your primary duty is to identify potential global drug development targets, conduct research into their respective development […]
Job Description: Job Title: (Junior) Bilanzbuchalter – Finance Associate (m/w/d) Location: Berlin Department: Finance Work Pattern: 40 hours Reporting to: Finance Director – Dublin Responsible for (staff): N/A This position will be responsible for supporting the site management team and third party finance/ accounting firm (local tax advisor) with standard processes such as AP invoice […]
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