דרושים Associate Specialist Manufacturing Automation ב-Msd ב-אירלנד

Job Description

A fantastic opportunity has arisen for aQC Stability Specialist.In this role, you will be responsible for oversight, management and coordination of the site Stability program and sample management functions. This position carries the remit and accountability to enable the site to meet compliance and regulatory requirements pertaining to Stability and Sample Management.

You will ensure the QC team objectives are effectively achieved, consistent with site requirements ensuring compliance, safety and reliable supply to our customers.

What you will do:

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

Liaise with logistics and warehouse personnel to communicate incoming samples for testing.

Maintain and manage the Stability Program at the site.

Author stability strategies for new and licensed products,

Develop, review and approve stability protocols as per the overall stability strategy.

Monitor Stability program execution – assess cycle time adherence, report KPIs, analyse root causes if/when required, and propose mitigation plans as needed.

Manage and maintain QC metrics and dashboards related to stability and sample management to report out on Key performance metrics

Design and update annual stability protocols as per applicable regulatory requirements

Review and approve stability data to support the assigned expiries and labelled storage statements,

Evaluate and report on stability data annually and as needed, including statistical analysis as appropriate.

Update Global Laboratory Information Management System (GLIMS) for all changes and addition of new stability requirements.

Reviews and approves key stability quality deliverables including GLIMS reports, Change controls, deviations and CAPAs in SAP.

Initiate and manage change controls associated with Stability Program, sample management QC methods, changes to processes pertaining to the QC Labs, updates to Specifications etc.

Initiate and manage deviations associated with Stability program, sample management, testing, processes etc

Assist with Implementation of standardised work, visual management, leaders standard work etc.

Develop program for QC SMEs for preparation for Regulatory Inspections and develop storyboard for key QC topics and processes including Stability and sample management

Be an advocate for continuous improvement.

In order to excel in this role, you will need:

Third Level science qualificationin Science, Engineering or in a relevant discipline, with operational excellence in GMP environment

Minimum of 5 to 7 years’ experience in Quality Control, Quality Assurance or Pharmaceutical or Biological Operations

Experience in QC (Stability and/or sample management an advantage)

Strong attention to detail with the ability to manage a complex scheduling activity to keep the group on track for success.

Strong ability to organise and prioritise work; ability to create and execute contingency and mitigation plans.

Ability to summarise data and plans into charts, graphs, diagrams, and tables.

Experience with SAP (or similar ERP system) and LIMS is beneficial.

Hands-on application of lean tools and techniques: standardized work, scientific problem solving, value stream mapping, capacity analysis.

So, if you are ready to:

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 energy, knowledge, innovation to carry out the following:

• Support and execute experimental design, data analysis and interpretation to resolve complex cell culture and / or downstream deviations.
• Support the process sciences team during small scale model run execution, including media & buffer preparation make up, equipment set up, run execution, sampling and data analysis.
• Author and review standard operating procedures, study protocols and reports as required.
• Support global regulatory submissions as needed.
• Support multidisciplinary teams (MS&T, quality, analytics, regulatory) for process improvement and troubleshooting.
• Assure effective application of Lean Six Sigma and Change Management tools in the Analytical Sciences group by:
• Secure continuity of an appropriate level of knowledge.
• Facilitate problem solving & risk assessment (FMEA) projects/meeting.
• Make problems visible and striving for continuous improvement.
• Support alignment and knowledge exchange with development organizations, other commercial nodes and external manufacturing partners.

What skills you will need:

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

• Bachelor’s degree (or higher) in in Biological Sciences/Chemistry /Chemical Engineering/Biological Engineering.
• 5 years directly related experience in academia, pharmaceutical or biotechnology company.
• Prior experience in drug substance process development, process characterisation studies, process performance qualification and validation, site readiness, batch record reviews, authoring regulatory CTD sections and/or working with external contract organisation for development and/or manufacturing.
• Experience in executing experimental programs in the laboratory.
• Working knowledge of statistical methods for DOE design and data analysis (e.g., JMP or Design Expert software).
• Experience with technology transfer, regulatory filing, and commercial drug substance manufacturing of vaccines is a plus.
• Knowledge of and experience in applying Six Sigma and Lean methodologies
• Desirable evidence of Continuous Professional Development.

Please don't hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process.

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

Current Contingent Workers apply

Language(s) Job Description:

*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

THERAPY MANAGER

Therapy Manager is responsible for Efficiently manage the therapy area by effectively reaching out to customers and increases product awareness, answer queries and introduce new products. Also responsible for Customer Focus and have industry knowledge and schedule and plan the frequency of calls and personally visit the targeted doctors as per agreed coverage list.

WHAT YOU WILL DO

• Imbibe the product related features/benefits including scientific information thereto, so as to effectively communicate with the medical doctors and handle product related customer queries
• Utilize customer focused selling techniques (CSSP), continually assessing the knowledge of the customer and strategize to maintain high customer confidence and customer knowledge of companyproducts.
• Maintain current, approved protocol (CSSP) and promotional materials to be included in sales presentation/ detailing.
• Contact customers on regular basis and deliver informative sales presentations based on customers need.
• Explore opportunities to develop new business in the assigned therapy area.
• Achieve and exceed the sales targets on a consistent basis through effective implementation of the sales promotion strategies and scientific initiatives.
• Constantly update the knowledge of disease and product area so as to facilitate scientific discussion with stakeholders to enhance productivity levels as expected by the Company.
• Carry out Product Visibility and such ancillary or incidental activities related to the Products of the Company or Products of any other Company as may be decided from time to time, in accordance with any arrangement or agreement entered by the Company with such other Company.
• Explore opportunities to develop new business avenues for assigned therapy area and territory.
• Tactically plans to generate tertiary demand generation.
• Plans and executes field working as per approved tour programs and reports into data management system at regular intervals as per company expectations.
• Takes follow-up initiatives on feedback and customer service requirements.
• Handles special product campaigns, new product launch campaigns as per Company’s plans.
• Covers the Nursing homes, clinics and hospitals as per agreed coverage requirements.
• Assists in the collection of receivables, as per company policy.
• Work collectively with other team colleagues in arranging speakers, displays, special programs and CMEs to meet the educational needs of customers.

WHAT YOU MUST HAVE

• Degree in Sciences / B Pharm
• Pediatric Vaccine experience is a must.
• 2 to 7 year’s relevant sales experience
• Proven experience in articulating data-driven findings to various audience levels and translating these findings into actionable recommendations.
• Relevant experience in therapeutic segment
• Must have vaccine knowledge and selling experience at corporate hospitals with Peads,
• B. Science / B. Pharmacy

WHAT YOU CAN EXPECT

• You will be a part of highly motivated sales team that seek to innovate in order to improve lives.

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 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 energy, knowledge, innovation and leadership to carry out the following:

• Provide technical support to the project and site automation teams.
• Maintain DeltaV DCS automation systems in a validated state.
• Design, develop, and maintain automation applications and infrastructure.
• Ensure that objectives are met in compliance with company requirements, safety standards, and reliable supply to customers.
• Provide regular updates on delivery, cost, and resourcing to the automation lead.
• Ensure that technical solutions adhere to corporate and compliance standards.
• Seamlessly transition new or modified automation systems from capital projects to ongoing operations.
• Lead continuous improvement efforts.
• Ensure the success of production support processes for DCS automation systems.
• Collaborate with the business on the effective use of automation solutions.

What skills you will need

• Bachelor's degree or higher in Automation Process Control, Computer Science, or Software Engineering (other engineering degrees considered based on experience).
• Extensive technical and operational expertise on DeltaV DCS systems.
• Extensive technical and operational expertise in data historian and reporting systems, computer system validation, and control system/shop floor integration.
• Understanding and application of S88 batch.
• Experience with facility commissioning and startup.
• Leadership in implementing and supporting automation solutions.
• Experience working in a GMP environment and with regulatory inspections.
• Strong project execution skills along with routine/support work planning and scheduling.
• Experience in mentoring and coaching junior engineers.
• Proficiency in reviewing and approving technical and compliance documentation.
• Vendor management skills.
• Knowledge of Lean Six Sigma methodology with demonstrable problem-solving skills would be beneficial
• Excellent communication, presentation, and interpersonal skills.
• Strong knowledge of pharmaceutical and manufacturing processes would be beneficial.

So, if you are ready to:

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

Current Contingent Workers apply

Language(s) Job Description:

*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.