ResponsibilitiesMarket identification within ANZ & entry strategy Prospecting for new partners in the chosen marketsShowcase Rubicon’s Capabilities & Products To Potential PartnersEvaluation of short-listed opportunities, negotiate for deal terms, prepare business case presentations.Negotiation of term sheets / definitive agreementsAlliance ManagementInfluence the cross functional team to drive the BD endeavors at organizational level Qualification & ExpeirenceMust have 10+ years of international BD experience in Finished Products Must have proven success in regulated marketsMust have travelled to assigned territories for customer meetings (not only CPhI)

ResponsibilitiesLead end-to-end supplier quality processes such as Vendor Change Notifications (VCNs), Supplier Quality Agreements (QAAs), and supplier complaints to ensure timely and compliant handling Evaluate supplier changes and requests using risk-based and analytical decision-making to protect product quality and supply continuity Review and approve supply chain records (VSCI) governing the use of materials, services, and equipment across the Lonza network Collaborate with cross-functional teams (Manufacturing, QC, Procurement, MSAT, Planning) to assess impact and manage risks effectively Maintain accurate supplier documentation, ensuring compliance with quality management systems, regulatory requirements, and data integrity standards Monitor and report key performance indicators (KPIs) related to supplier quality processes, identifying risks and driving continuous improvement Act as a global point of contact for supplier quality topics, supporting audits, inspections, and alignment across internal and external stakeholders

ResponsibilitiesMajor Tasks Job Description Summary Presents pharmaceutical products to prescribing healthcare professionals, including generalist practitioners, specialists and hospital professionals. Delivers therapeutic information in compliancewith ethical rules and according to the marketing and sales strategies defined for the product line. May use various e-detailing platforms such as web-based or video conferencing/training, data specific web sites, physician portals and blogs.

Responsibilities Stability Program Ownership Approve stability protocols — long-term, accelerated, intermediate, in-use, and photo-stability — per ICH Q1A(R2), Q1B, and Q1E. Own stability schedule across all marketed products and ongoing commitments. Approve product stability reports for regulatory submissions per ICH Q1E. Approve annual stability protocols for marketed products and ongoing commitments.  Compliance & Investigations Approve all stability OOS / OOT investigations (Phase 1, 2, 3) and CAPAs in QMS. Be a key audit-facing person for Stability during regulatory and customer audits. Drive ALCOA+ and data integrity compliance — audit-trail review, individual logins, paper-on-glass elimination.  Chamber & Inventory Management Drive temperature mapping of stability chambers (initial qualification + yearly re-mapping; hot / cold spot identification). Coordinate chamber alarm and excursion response — chamber recovery, sample impact assessment. Maintain stability sample inventory dashboards — due-date tracking, OOS / OOT count.  People & Cross-Functional Coordination Manage 3 – 5 across Senior Executive, Junior Executive, and Trainee levels. Mentor junior executives and trainees on stability HPLC and classical analysis. Coordinate with QA Stability, F&D / ADL / RA on protocols, climatic zone strategy, and submissions.Qualification & ExperienceB.Pharm / M.Pharm Experience 8 – 12 years; multi-section / department-coordination level (OSD experience preferred).

ResponsibilitiesPerform sampling of raw materials (RM), packaging materials (PM), and water systems as per approved sampling procedures. Conduct analysis of RM and PM as per specifications, including identification, physical, and chemical tests applicable to materials. Perform routine water analysis (e.g., purified water, potable water) as per defined specifications and standard test methods. Execute tests such as identification (FTIR/UV/chemical), loss on drying, pH, conductivity, and other applicable tests specific to RM/PM/Water. Ensure proper labeling, handling, and storage of RM/PM/Water samples during sampling and analysis. Maintain accurate raw data, analytical records, and worksheets related strictly to RM/PM/Water activities. Ensure timely completion of sampling and analysis to support material approval and production requirements. Follow approved SOPs, STPs, and specifications applicable to RM/PM/Water without deviation. Ensure adherence to data integrity principles (ALCOA+) in all RM/PM/Water-related activities. Identify and report OOS (Out of Specification) and OOT (Out of Trend) results observed during RM/PM/Water analysis. Maintain cleanliness, safety, and discipline in sampling and laboratory areas related to RM/PM/Water. Qualification & ExperienceQualifications: B.Sc. / Msc. / B.Pharm Experience: 0–2 years of experience in a pharmaceutical company (OSD preferred).

Responsibilities Stability Sample Management Manage stability sample withdrawal, storage, and handling as per approved stability protocols and ICH Q1A(R2). Perform sampling of stability batches at defined time-points — initial, intermediate, accelerated, long-term, photo-stability, in-use, and stress studies. Ensure proper labelling, storage conditions, and segregation of stability samples in designated stability chambers. Stability Testing Conduct analysis of stability samples as per approved specifications and test procedures. Execute tests including Assay, Related Substances (HPLC), Dissolution profile, Content Uniformity, and physical parameters (description, hardness, friability, DT, water content) as applicable to stability study requirements. Ensure timely completion of stability testing and reporting as per stability protocol timelines. Document results in stability protocols, summary sheets, and reports. Chamber Monitoring & Trending Monitor and record stability chamber conditions (temperature, relative humidity) as per defined frequency. Maintain stability chambers — 25°C/60% RH, 30°C/65% RH, 40°C/75% RH. Respond to chamber excursions per SOP. Participate in trending and interpretation of stability data. Ensure timely review and notification for any trending abnormalities or failures. Analytical Instruments to be Handled Stability Chambers (25°C/60% RH, 30°C/65% RH, 40°C/75% RH) HPLC, UV-Vis Spectrophotometer Dissolution Apparatus, Disintegration Tester Hardness & Friability Testers, KF auto-titrator pH meter, Analytical balances Documentation & Compliance Follow ALCOA+ principles for data integrity. Adhere to cGMP, GLP, ICH Q1A / Q1B / Q1E, and Schedule M norms. Maintain stability raw data, worksheets, and analytical records. Participate in internal audits, regulatory inspections, and CAPA closure. Ensure calibration and preventive maintenance of stability chambers and analytical instruments is up to date.Qualification & ExperienceQualification B.Sc / M.Sc / B.Pharm Experience 1 – 3 years (OSD experience preferred).

ResponsibilitiesTranslate technical, operational, and organizational documents across various departments (Quality, Production, Engineering, HR, and Communication) with accuracy, consistency, and in accordance with internal standards. Ensure linguistic quality, clarity, and alignment with site terminology and regulatory expectations. Maintain documentation alignment with approved templates, controlled language, and quality system requirements. Act as the Subject Matter Expert (SME) for translation workflows and tools, supporting teams in the preparation, wording, and structure of documents. Guarantee the timely delivery of translations, proactively managing workload and shifting priorities to meet critical site due dates. Review, edit, and proofread translated content to ensure absolute correctness and compliance. Collaborate closely with team members and Operations to define priorities, secure customer satisfaction, and guarantee readiness for documentation implementation.Qualification & ExpeirenceDegree in Translation, Linguistics, or a related field; or equivalent professional experience in technical translation. Proven experience translating technical documentation, ideally within a pharmaceutical, chemical, or highly regulated GxP environment. Excellent command of German and English (written and spoken) is essential, with the ability to capture complex technical nuances in both languages. Strong attention to detail and a commitment to maintaining consistency across large volumes of documentation.

ResponsibilitiesDevelop, implement, and maintain the quality management system (QMS) in accordance with regulatory requirements and industry standards. Lead and manage quality assurance activities, including audits and investigations. Collaborate with cross-functional teams to ensure product quality throughout the product lifecycle. Monitor and analyze quality metrics to identify trends and areas for improvement. Prepare and review quality documentation, including standard operating procedures (SOPs), validation protocols, and reports. Provide training and guidance to staff on quality assurance practices and regulatory compliance. Drive continuous improvement initiatives to enhance product quality and operational efficiency. Qualification & ExpeirneceExp: 7 Years to 9 YearsEducation: Master degree in Life Sciences, Chemistry, Engineering, or a related field. Minimum of 7 years of experience in quality assurance within the pharmaceutical/ Chemical/life sciences or biotechnology industry. Strong understanding of regulatory requirements (e.g., FDA, EMA, NABL, ANAB) and quality standards (e.g., ISO, GMP). Excellent analytical, problem-solving, and communication skills. Ability to work collaboratively in a fast-paced, team-oriented environment.

ResponsibilitiesSafely perform operations to meet quality expectations throughout the process. Ensure you are adequately trained to perform tasks/assignments. Clean up equipment and working areas during and after operations. Complete the volume of work required to achieve group/departmental goals and meet deadlines. Implementing kaizens and to maintain 6S in Manufacturing area To report and record the deviations observed during the activity and support AM/PM activities Contribute to support functions of the lab (e.g., maintain equipment, prepare reagents, restock lab supplies, waste disposal). Communicate the status of operations and bring deviations to the attention of a supervisor. Ensure all applicable logbooks have been filled out completely as required by current procedures. Accurately perform procedures independently and Perform routine troubleshooting. Identify opportunities for process improvement. Participate in process improvements under the guidance of a supervisor or Scientist. Take the necessary action to resolve any unsafe conditions. Develop improvement ideas, review impact of changes, and document all work. Perform and interpret analytical evaluations of products and intermediates. Safe handling of solvent distillation, solvent transfer.

ResponsibilitiesIdentify, plan, and implement validation requirements across equipment, instruments, utilities, and manufacturing/testing processes in a cGMP greenfield facility. Prepare and execute IQ/OQ/PQ protocols; coordinate and support cleanroom qualification, facility and utility qualification activities; create and govern the Validation Master Plan (VMP); review, approve, and maintain validation protocols, SOPs, and technical documentation in a controlled, compliant manner (cGMP, GAMP 5, FDA 21 CFR Part 11, ISO 9001). Identify and assess validation changes, deviations, and CAPAs; ensure remediation and closure of compliance actions; conduct risk assessments (FMEA, impact assessments); perform trend analysis of non-conformances and data reviews; ensure QMS conforms to ISO 9001a and organisational policies; lead audits and regulatory inspections; drive root cause analysis and timely closure of corrective actions; collaborate with cross-functional teams to drive validation deliverables. Acts as the quality face to customers for products; performs process audits to identify gaps and implement corrective actions; supports technology transfer and global projects; stays current with industry regulations and trends; supports EHS/OSHA as required; operates in a multi-cultural, multi-time-zone environment; demonstrates strong networking and problem-solving skills to influence across organizational levels. Strategic objective: build a strong Validation Team to enable successful product transfers; works closely with Production, Maintenance, and cross-functional teams; engages with suppliers and service providers.Qualification & ExpeirneceEducation: Degree in Biotechnology or Master’s degree in Life Science/pharmaceuticals; related life-science/engineering background acceptable depending on the role. Experience: Minimum 6 years’ total experience, with at least 5 years in a quality validation role; experience in reputed pharma industries or research institutes; prior involvement in projects, facilities startups, and technology transfer preferred. Deep knowledge of IQ/OQ/PQ lifecycle; proficiency in FMEA and impact assessment; understanding HVAC principles; strong problem-solving, analytical, and communication skills; ability to lead change and build cross-functional relation