Production Operator (6-Month Fixed Term Contract) Job Purpose: We are seeking an experienced Production Operator to join our team. The successful candidate will work across multiple manufacturing activities, including manufacturing, filling, packaging, serialisation, inspections and in-process testing, to support the reliable production of high-quality pharmaceutical products. This role requires full availability to work 2-cycle shift. A strong commitment to cGMP, safety, accuracy, and teamwork is essential. Key Responsibilities: Operate, monitor, and adjust production, filling, packaging, and serialization equipment as trained. Perform IPC (In-Process Control) tests, inspections, and quality checks. Complete batch records, logbooks, and electronic documentation in accordance with cGMP. Implement and maintain high standards of cGMP and SOP compliance in all activities. Carry out area clearances, equipment cleaning, and housekeeping to ensure audit readiness. Report any deviations, OOS results, inefficiencies, or breaches of SOPs, safety or environmental procedures. Make minor machine adjustments where required to maintain efficient operations. Support the Operations schedule by working collaboratively with team members and other departments (QS, QC, Engineering, Maintenance, Warehouse). Assist in the training of new Operators and maintain your own training records up to date. Participate in Continuous Improvement (CI) / Lean activities and site projects. Wear appropriate PPE and work safely at all times, reporting any incidents, injuries, or material loss (spills/contamination). Transfer between Operations areas as required to support business needs. Qualification / Experience / Skills: The successful applicant must possess the following knowledge, skills, qualifications, attributes and experiences. Previous experience in manufacturing operations (essential). Experience in the pharmaceutical, medical device, food, or other GMP-regulated sector (strong advantage). Strong understanding of cGMP and SOP-based working practices. Experience with batch documentation, IPC testing or equipment operation. Basic computer literacy. Experience with ERP/MES systems (e.g., SAP) is beneficial. Full availability to work early and late rotating shifts if required. Leaving Certificate or equivalent. Technical or manufacturing qualifications are an advantage. Key Competencies Accuracy, strong attention to detail, and high standards of documentation. Commitment to quality, safety, and compliance. Ability to work effectively within a team and maintain positive working relationships. Strong communication skills and a proactive attitude. Flexibility to support different Operations areas and changing priorities. Demonstrated initiative and willingness to contribute to CI / Lean activities. Respect for confidentiality, professionalism, and alignment with company values. Helsinn Birex Pharmaceuticals - we are a global pharmaceutical company and a leader in supportive care focused on improving the health and quality of life of patients with cancer and chronic diseases. For more information, please visit our company website ( Skills: Production line GMP Manufacturing Pharmaceutical Production Operator Benefits: Health Insurance Parking Space with EV Charger Subsidized Canteen Pension Scheme
Position Overview We are seeking a skilled and experienced Regulatory Affairs Manager to join our Regulatory Affairs function in Ireland. This role will be responsible for overseeing day-to-day regulatory activities, using expert regulatory CMC capabilities to provide regulatory guidance to the team. This position requires a combination of teamwork with hands-on involvement in regulatory operations, with a particular focus on GMP compliance, regulatory quality assurance, and regulatory CMC-related activities to support our manufacturing site. This position requires management of a small regulatory team. Key Responsibilities Team Leadership: Lead, develop, and manage the local Regulatory Affairs team to ensure high performance, collaboration, and compliance with training and development plans by providing guidance, support, and decision-making assistance. Support team development through mentoring and knowledge sharing. Manage departmental budgets and resource allocation to support current and future regulatory requirements. Regulatory Operations: Plan, oversee, and actively support the submission of new Marketing Authorisation Applications (MAAs), variations, renewals, and other post-approval activities in the territories assigned, according to the global strategies. Handle complex regulatory submissions and provide hands-on support for critical projects. Ensure timely and compliant submissions to EU or other international regulatory agencies, using validated publishing tools. Regulatory CMC Manage and maintain a comprehensive overview of Modules 2.3 and 3 of the dossiers across all applicable territories. Participate in change control processes to assess the regulatory impact of proposed changes to products, manufacturing processes, or facilities. Track and evaluate the impact of the CMC changes across different markets. Lead the preparation and review of the CMC documentation for the products manufactured on site, including the adaptation of CMC sections to meet the specific regulatory requirements of various territories. Handle complex regulatory submissions and provide hands-on support for critical projects. GMP and Regulatory Quality Assurance: Maintain regulatory compliance between registered MA dossiers and manufacturing/site operations. Oversee compliance with regulatory requirements for manufacturing, packaging, testing, and distribution activities. Review and approve from a regulatory point of view, when necessary, GMP documentation, product artworks, and other regulated documents. Support Quality Assurance during inspections and audits. Ensure alignment between regulatory commitments and site operations. Support preparation of responses to Health Authorities queries, in collaboration with other functions, other Helsinn affiliates and/or partners as appropriate. Compliance Management: Monitor regulatory changes affecting manufacturing operations and implement updates to processes and procedures as necessary. Support organizational changes and process improvements from a regulatory perspective Authority Interactions: Serve as the primary contact as MAH representative for interactions between HBP with regulatory authorities (e.g. HPRA, EMA), including attending meetings, managing correspondence, and preparing responses to queries. Cross-functional Collaboration: Collaborate closely with Corporate Global Regulatory Affairs to align local activities with global regulatory strategy. Work closely with Quality, Manufacturing, Supply Chain, R&D, and Commercial teams and provide regulatory guidance and expertise to internal stakeholders. Provide regulatory support to internal and external stakeholders, including provision of documentation, submission guidance, and communication of regulatory changes. Required Qualifications and Experience A degree in Pharmacy, Life Sciences, or a related discipline. Postgraduate qualifications in Regulatory Affairs or Pharmaceutical Sciences are advantageous. Minimum of 7 years of relevant experience in Regulatory CMC within the pharmaceutical industry for European or global activities. At least 4 years of experience in CMC regulatory writing and preparing documentation is desirable. Experience in Regulatory Quality Assurance is highly desirable. In-depth knowledge of European regulatory requirements (CP, DCP, MRP, national procedures) and familiarity with ROW markets is a plus. Strong understanding of GMP, GDP, and pharmaceutical quality systems. Previous experience supporting regulatory inspections (GMP, GCP, or regulatory audits). Proven experience in project management and cross-functional collaboration. Key Competencies Strategic and analytical thinking with a proactive approach to regulatory challenges. Hands-on approach to regulatory activities with attention to detail. Excellent communication skills, both written and verbal, with experience interacting with health authorities. Demonstrated ability to manage multiple projects and deadlines in a dynamic environment. High attention to detail and commitment to regulatory excellence and compliance. Problem-solving skills with a focus on practical solutions. Important interpersonal and managerial skills, with a focus on team mentoring and development. Helsinn Birex Pharmaceuticals - we are a global pharmaceutical company and a leader in supportive care focused on improving the health and quality of life of patients with cancer and chronic diseases. For more information, please visit our company website ( Skills: Regulatory Affairs CMC Benefits: Health Insurance Performance Bonus Pension Scheme Parking Space with EV Charger Flex Time Work from Home Scheme
