QUALITY SPECIALIST 4 MONTH CONTRACT On behalf of our client, a leading healthcare company, we are currently recruiting for a Quality Specialist for a 4 month contract role. The role will report to the Quality Manager. In this role your core responsibilities will include: Responsibilities *Support the Quality Manager and Qualified Person in maintaining compliance with Good Manufacturing Practice (GMP), for Medicinal Products, Quality Systems, local and corporate procedures, regulatory requirements, and industry standards. *Assist the Quality Manager and Qualified Person in the development of continuous improvement and compliance projects within the Quality Department. For example - Support projects as the business expands within the compounding services division. Requirements: Daily activities *Ensuring that the handling, order processing and approvals of patient scripts is completed as per the requirements of the Medical MIA. *Reviewing and approving the Spanish patient scripts from Medical in Spain and updating the Patient ID log accordingly. *Request the removal of stock from the quarantine block in SAP and for the verification step for Patient Specific TPN Orders prior to manufacture by Medical in Spain. *Review and co-ordinate any CAPA investigations for deviations at the Spanish site which may impact on product quality for products supplied to Medical. *Co-ordinate customer and supplier complaints - including investigations, reporting, and trending. Ensure the management of the SAP disposition of non-conforming products. Supporting Activities *Defining and periodically updating Quality Procedures in conjunction with operating staff, while ensuring compliance with GMP and GDP. *Prepare information in advance for presentation at the Quality Review Board meetings. *Assist in the completion of internal audits of GMP systems, assessing and verifying planned corrective and preventive actions and reviewing the effectiveness of the corrective and preventive actions taken. *Assist the Quality Manager in maintaining copies of the approved Specifications in the Document Management system and ensuring the relevant personnel are included in the distribution list *Recording, investigating and reporting incidents and deviations to the Quality Manager and Qualified Person. *Assisting Process Owners in assessing risks and assigning counteractive measures. *Documenting and managing relevant change controls through to completion. *Ensure the adherence to the stability schedule. *Management of the stability data for the support of the expiry dates. *Assist in the co-ordination and documentation of product recalls and mock recalls. *Support Pharmacovigilance and Compliance activities as required. *Responsible for issuing protocol and report numbers and maintaining associated logs. *Compilation of reports in a timely manner, as requested. *Assigning resources to all investigations, ensuring the acquisition of the necessary information. *Ensuring implementation, closure and effectiveness of all Corrective & Preventive Actions generated. Requirements: *The ideal candidate will have 3- 5 years experience in a pharmaceutical/regulated background with strong working knowledge of compounding, GMP and regulatory expectations. *Bachelors degree or higher; ideally in a related Science discipline *Demonstrated ability in quality systems support *Knowledge of EU quality related pharmaceutical regulations *Experience in compounding and working in a MIA environment *Knowledge of Industry Best Practices for quality and compliance related topics *Ability to process technical information *Accuracy and excellent attention to detail are key attributes along with strong organisational skills *Strong verbal and written communication skills *A proactive and collaborative work style and the ability to work with multiple priorities and deadlines *Proven decision-making capability with accountability and responsibility *SAP experience For a full Job Spec and to apply for this role please call Linda on or e-mail Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. Tel: #LI-LD1
On behalf of our client, we are currently recruiting for a Qualified Person for Pharmacovigilance (QPPV). This person can be predominantly remote with occasional travel to Irish office. Purpose of Job Act as company nominated EEA QPPV to meet all EEA QPPV responsibilities (as defined in current EU Directive 2001/83/EC, GVP Module I and II). Limits of Role The post holder is not expected to authorise expenditure. If required, this will be in agreement with the Associate Director, Pharmacovigilance. Main Duties and Responsibilities The EEA QPPV is responsible for the functions described below and, where appropriate, in the client-specific job description. Overview of Safety *To have an overview of medicinal product safety profiles and any emerging safety concerns. *Have an awareness of any conditions or obligations adopted as part of the client MAs and other commitments relating to safety or the safe use of the product. *Ensure that signal management activities are conducted appropriately. Risk Management Plans *Have an awareness of risk minimisation measures. *Be aware and have sufficient authority over the content of risk management plans. *Be involved in the review and sign-off of protocols of post-authorisation safety studies conducted in the EEA or pursuant to a risk management plan agreed in the EEA. *Have an awareness of post-authorisation safety studies requested by an EEA competent authority including the results of such studies. Conduct of Pharmacovigilance *Ensuring conduct of pharmacovigilance and submission of all EEA pharmacovigilance-related documents are in accordance with the legal requirements and GVP. *Ensure the necessary quality including correctness and completeness of pharmacovigilance data submitted to the EEA competent authority. *Ensure a full and prompt response to any request from the competent authorities in the EEA member states and EMA. *Provide input into the preparation of regulatory action in response to emerging safety concerns (e.g., variations, urgent safety restrictions, and communication to patients and healthcare professionals). *Act as a single pharmacovigilance contact point for the competent authorities in EEA Member States and EMA on a 24-hour basis and also as a contact point for pharmacovigilance inspections. Quality System *Have sufficient authority to influence the quality system and pharmacovigilance activities across the Company. *Have oversight of the information contained in the pharmacovigilance system master file (PSMF); to ensure it is an accurate and up-to-date reflection of the Companys pharmacovigilance system and pharmacovigilance metrics are recorded appropriately. *Conduct and lead Pharmacovigilance audits when applicable for clients and partners and respond to any deficiencies in conjunction with the MAH ensuring correct CAPAs are applied and completed. Local QPPV role *Act as National QPPV to support the client EEA QPPV in management of pharmacovigilance activities in Ireland. General Responsibilities Support the company and clients in pharmacovigilance meetings with authorities and or other relevant meetings. Mentoring and training of new and existing employees as required on Pharmacovigilance To act as a source of pharmacovigilance expertise for the Company All employees of have a responsibility under the Health and Safety at Work etc Act 1974 to ensure their own and others safety whilst at work and to be aware and work within the framework of company Health and Safety Policy and the associated Standard Operating Procedures. Qualifications and Role Requirements Life science degree, preferably within the sphere of pharmacy, medicine, veterinary medicine, chemistry, pharmaceutical chemistry and technology or biology. A minimum of 5 years pharmaceutical industry experience. The EEA QPPV shall reside and operate in the EEA. For a full Job Spec and to apply for this role please call Linda on or e-mail Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. Tel: #LI-LD1 Skills: qppv pharmacovigilance
On behalf of our client, we are currently recruiting for an Assessor, Methodology (Biostatistics) - Centralised and Clinical Trials Licensing Human Products Authorisation and Registration. This is a 3 year fixed term contract role. It is a hybrid role with 2 days per week in the office and 3 days remote. It is a 35 hour week. ROLE SUMMARY The Human Products Authorisation and Registration (HPAR) Department provides human medicines licensing services. The Methodology team is part of the Centralised and Clinical Trials licencing section delivering assessments for products authorised through the centralised (EU) mechanism, and for clinical trials. The Methodology team consists of clinical pharmacology/pharmacokinetic assessors and biostatisticians/statistical assessors. The position of Assessor, Methodology (Biostatistics) will be based in the Centralised and Clinical Trials licensing section and will report to the Executive Assessor (Methodology). The Assessor, Methodology (Biostatistics) will use their statistical and professional expertise to lead the assessment and review of the statistical aspects of marketing authorisation applications and clinical trial applications. The assessment involves report writing, contributing to benefit risk assessment. The Assessor, Methodology (Biostatistics) will critically analyse complex clinical and scientific information, making sound judgements on the value of the statistical methodologies employed, and write informative assessment reports for a multi-disciplinary readership. The Assessor will provide expertise on good drug development, interacting with medical colleagues, multi-disciplinary advisory committees and company representatives, as required. The role holder will also provide in-house statistical expertise to other technical sections in HPAR, as required. The Assessor will work closely and maintain effective working relationships with members of the Methodology team, other members of the section and with members of the department, to ensure effective co-ordination and co-operation across all areas of assessment and to ensure that the objectives of the department are met. KEY RESPONSIBILITIES Technical Objectives * Strategic Objectives Operational Objectives *Work with the Executive Assessor (Methodology) and Section Leadership Team to meet the goals and objectives of the section *Work with the Executive Assessor (Methodology) and Section Leadership Team to plan and organise work tasks that ensure efficient delivery of work *Assist in the compilation of data and preparation of reports as required *Promote a positive, open, friendly and professional working environment *Attend Working Groups/Committees/meetings at the European Medicines Agency (EMA), as required Quality and Knowledge Management *Assist the managers of the Section to ensure the effective implementation of the Quality Management System within the section *Assist the managers of the Section to ensure effective mechanisms are in place to capture, store and communicate key information, experience and knowledge gained by the section QUALIFICATIONS AND EXPERIENCE To be considered for this post, candidates should meet the following criteria: A postgraduate qualification (MSc/PhD) (NFQ level 9 or 10) in statistics, medical statistics or biostatistics A relevant 3rd level honours degree (NFQ level 8) in mathematical, life science, or healthcare discipline (e.g. mathematics/applied mathematics, biostatistics, statistics, biomedical science, pharmacology, pharmacy, genomics, psychology) Experience employing analytical thinking on complex data and statistics, and ability to make appropriate and tailored recommendations, comprehensible by multidisciplinary audience Sound understanding of statistical methodology relevant to the regulation of medicines and clinical trials, and emerging methodologies relevant to the field of statistics and medicines regulation Knowledge and understanding of the drug development process (pre-clinical, quality, clinical and post-approval) with understanding of drug development as a continuum Knowledge and understanding of the clinical trial process, different clinical trial designs and various statistical approaches that may be used Experience and knowledge with statistical software packages, standard office software (Word, Excel, PowerPoint), cloud-based platforms (Microsoft Teams) and communication tools (Outlook) Ability to evaluate and critically appraise complex information from a variety of sources and make effective decisions Self-starter, accountable, capable of effective communication, negotiation and decision making Motivated to further develop professional skills and competencies Flexible to adapt to changing priorities and take responsibility to ensure success Good strategic ability (problem-solving, critical thinking, cross-functional thinking) Strong organisational skills, including the ability to prioritise workload Excellent oral and written communication skills, excellent attention to detail Passion for knowledge sharing and dissemination of statistical expertise, and a willingness to contribute to peer-to-peer learning. The ability to work as part of a cross-functional team and clearly communicate statistical issues and methods to multidisciplinary audiences In addition, the following would be considered an advantage: Experience in applying statistical methods in biomedical research, pharmaceutical or CRO industry or drug regulatory agency Motivated to quickly develop a sound understanding of a wide range of statistical and clinical trial methodology, including state-of-the-art techniques, relevant to the regulation of medicinal products across the breadth of the drug development process Knowledge and experience of centralised licensing and clinical trials regulatory processes Experience and knowledge with statistical software packages such as R or SAS Knowledge and experience of regulatory (ICH, EMA and FDA) guidelines relating to the regulatory requirements for medicines and clinical trials For a full Job Spec and to apply for this role please call Linda on or e-mail Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. Tel: #LI-LD1 Skills: statistics biostatistics biostatistician
