דרושים Intern Placement - Operations ב-Msd ב-אירלנד

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Job Description

Bring energy, knowledge, innovation to carry out the following:

• Maintaining and supporting the Stability Program at the site.
• Supporting stability strategies for new and licensed products.
• Moving lab samples internally around the building from warehouse to labs and vice versa
• Assist in developing stability protocols as per the overall stability strategy.
• Pulling samples at required timepoints per stability protocol and submitting to the labs for testing.
• Managing and reconciling Stability Inventory and Managing on GLIMS.
• Designing and/or updating annual stability protocols as per applicable regulatory requirements.
• Reviewing and approving stability data to support the assigned expiries and labelled storage statements.
• Evaluating and reporting stability data on an annual basis and as needed, including statistical analysis as appropriate.
• Updates Global Laboratory Information Management System (GLIMS) for all changes and addition of new stability requirements when required.
• Ensures that all stability activities comply with cGMP, including acting as auditee designee for CQAC/Regulatory Bodies /third parties site inspection.
• Actively engage with wider business, site and above-site, to accept demand for SAP Quality Data changes.
• Assist in maintaining the QC plan based on the laboratory workload and known constraints, such as the QC equipment qualification status, calibrations and maintenance plans, personnel availability and training on the techniques including personnel and equipment assignment, and the expected sample schedule.
• Assess QC Laboratory capacity (internal and contract labs) based on demand from multiple work centers – purchased materials, production, environmental monitoring, inventory, and stability monitoring.
• Liaise with logistics and warehouse personnel to communicate the incoming/outgoing sample schedule.

What skills you will need:

In order to excel in this role, you will more than likely have:

• Experience with GLIMS – Global Lab Information Management Systems.
• Project Management experience
• A proven ability to deliver on tight timelines.
• A Higher Science Degree (MSc, PhD) with industry experience.
• 3+ years industry QC experience.
• MPS (Manufacturing Process Stream) experience is a must.
• Knowledge of domestic and international GMP regulations, cGMP’s, policies, performance and budget management.
• Excellent trouble shooting and problem-solving skills.
• Ability to challenge the status quo with a continuous improvement mindset.
• Ability to think logically and be proactive under pressure
• Proven ability in using a wide variety of lean tools and building capability within teams.
• Excellent written and oral communication skills.
• An understanding of cGMP requirements for Laboratory Operations and/or systems and compliance.
• Required to work on their own initiative in addition to working as part of a team.
• Excellent time management & organisational skills
• An understanding of analytical methodology
• Demonstrated understanding of continuous quality / process improvement tools (As defined by the site, e.g., DMIAC, Lean QA, 5S etc) desirable.
• Proven ability around working cross functionally, focusing on meeting, and tracking to schedules and embracing an interdependent work culture.
• Organisation Skills – Ability to manage multiple priorities and know when to escalate issues for resolution

Please feel free to speak to us about what flexibility means to you during your application.

So, if you are ready to:

Invent solutions to meet unmet healthcare needs,
please apply today.

Current Contingent Workers apply

*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.

Job Description

Bring your energy, knowledge, and innovation to:

• Reviews and approves discrepancy reporting, investigations and CAPAs associated with all areas of Manufacturing operations, Quality Control, Engineering and Supply Chain.

• Review and approval of Manufacturing batch records.

• Liaises with internal partners (e.g. Manufacturing Operations, Manufacturing & Science Technology (MS&T), Engineering functions etc) in support of daily operations.

• Responsible for supporting execution of an effective Quality system and accountable for quality oversight of quality management systems (CAPAs, Change Controls, Deviations Batch Documentation Review).

• Coordinate with peer Quality groups to ensure on-time disposition of commercial Drug Substance.

• Ensures clear communication on issues and timely escalation as applicable.

• Provide QA oversight to the qualification/validation, technical transfers, regulatory approvals and commercial/clinical operations at the facility.

• Review/Approval of validation/Qualification/verification protocols and reports associated with new product or material entry.

• Helps maintain site practices and procedures related to facility start-up, instrument qualification, usage, technology transfer execution, and commercial manufacturing.

• Responsibility for adhering to domestic and international GMP regulations, cGMP’s, company policies, leadership behaviors, and performance and budget management.

• Provide support and expertise for the preparation of regulatory submissions, inspection readiness activities, during health authority inspections including interaction with inspectors, responses to inspection observations, and monitoring of follow up actions.

• Champion site metrics to ensure targets are achieved, met and counter measures in place when applicable.

• Representing Quality on multidisciplinary teams.

• Executing company policies.

• Ensures new/revised quality system requirements are deployed to the Site.

• Ability to work on his/her own initiative in addition to working as part of a team. Must be able to work across a team matrix in order to meet accelerated timelines.
  

To excel in this role, you will have:

• Degree or post-graduate qualification in Science, Pharmacy or equivalent.

• 4+ years experience in QA or related function.

• Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies & in-depth understanding of site level products & related processes.

• Demonstrated expertise to effectively communicate within all levels of the organization around concepts of design controls, design verification and validation activities; production & process controls; Corrective & Preventive Action (CAPA), complaints & risk management; & product quality improvement using tools such as six sigma, DFR, etc.

• Demonstrated collaboration, negotiation & conflict resolution skills.

• Excellent communication skills (written and oral).

• Required to work on his/her own initiative in addition to working as part of a team. Must be able to work across a team matrix in order to meet accelerated timelines.

• Demonstrated understanding of continuous quality / process improvement tools (As defined by the site, e.g. DMAIC, Lean QA, 5S etc).

• Experience in performing internal audits and participating in external audits.

• Exceptional analytical, problem solving & root-cause analysis skills.

• Ability to multi-task and handle tasks with competing priorities effectively.

• Strong technical aptitude (i.e. able to read & comprehend technical documentation & execute procedures), global regulatory experience & demonstrated experience interfacing with regulators.

• Experience with working in a multinational organisation.

• Strong operations support background ensuring value added and effective quality oversight
  

please apply today.

Current Contingent Workers apply

*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.

Job Description

Associate Specialist- Data Visualization

As an Associate Specialist in Data Visualization, you will be developing compelling data visualizations solutions to enable actionable insights & facilitate intuitive information consumption for internal business stakeholders. The ideal candidate will demonstrate competency in building user-centric visuals & dashboards that empower stakeholders with data driven insights & decision-making capability.

Responsibilities:

• Develop user-centric scalable visualization and analytical solutions, leveraging complex data sources to create intuitive and insightful dashboards. Apply best practices in visualization design to enhance user experience and business impact.

• Collaborating with Data Viz leads and stakeholders to define key metrics, KPIs, and reporting needs. Participate and contribute in workshops to develop user stories, wireframes, and interactive visualizations.

• Partner with data engineering, data science, and IT teams to develop scalable business-friendly reporting solutions. Ensure adherence to data governance, privacy, and security best practices.

• Identify opportunities for automation, streamlining manual reporting processes through modern visualization technologies and self-service analytics enablement.

• Ensuring timely delivery of high-quality outputs, while creating and maintaining SOPs, KPI libraries, and other essential governance documents.

• Continuously innovative on visualization best practices & technologies by reviewing external resources & marketplace

Required Experience and skills:

• 2+ years of experience in business intelligence, insight generation, business analytics, data visualization, infographics, and interactive visual storytelling

• Hands-on expertise in BI and visualization tools such as Power BI, PowerApps, Qliksense, MicroStrategy, and ThoughtSpot

• Experience of data engineering and modeling, including ETL workflows, Dataiku, Databricks, Informatica, and database technologies like Redshift and Snowflake, with programming skills in SQL and Python.

• Knowledge of pharma commercial data sources, including IQVIA, APLD, Claims, Payer, Salesforce, Financials, Veeva, Komodo, IPSOS, and other industry datasets to drive strategic insights is plus

• Experience in pharmaceutical commercial analytics, including Field Force Effectiveness, customer engagement, market performance assessment, as well as web, campaign, and digital engagement analytics is plus

• Experience in agile ways of working, including Agile/Scrum methodologies, iterative development, and continuous improvement in data visualization and analytics solutions.

• Good problem-solving and communication skills, with the ability to interpret data and provide actionable insights while effectively working in cross-functional environments.

• Basic understanding of product management principles, focusing on developing user-centric, scalable analytical solutions aligned with business needs.

• Familiarity with agile ways of working, including exposure to Agile/Scrum methodologies and participation in iterative development and continuous improvement initiatives in data visualization and analytics projects.

• Strong learning agility, with the ability to quickly adapt to new tools, technologies, and business environments while continuously enhancing analytical and technical skills.

Current Contingent Workers apply

*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.