דרושים ב-Msd ב-Ireland

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:

• Develop and coach the Quality Control team and drive a high-performance organisational culture that accommodates rapid growth and highly dynamic expectations, ensuring attainment of site operational and development goals.
• Perform a variety of routine Biochemistry and Cell Biology analytical testing techniques and associated documentation; including but not limited to ELISA, PCR, Bioassays and Cell Culture, water and cleaning validation sample testing and compendial methods in compliance with GMP requirements.
• Perform advanced assays requiring precise analytical skills and an understanding of biological and chemical principles.
• Complete special project/protocol testing in a timely manner under direction of Project Leads and/or Area Lead.
• Contribute to a team setting within the laboratory and project activities and potentially with other work teams to increase efficiency, solve problems, generate cost savings, improve quality, and provide new product support.
• Provide support and expertise for the preparation of regulatory submissions, inspection readiness, health authority inspections including interaction with inspectors, responses to inspection observations, and monitoring of follow up actions.
• Support activities including general lab readiness, audit readiness, laboratory equipment qualification and analytical method technical transfer, verification and validation.
• Champion site metrics to ensure targets are achieved, met and counter measures in place when applicable.
• Consistently deliver on specific area Key Performance Indicators.
• Operate to the highest standards of Safety, Quality, and Compliance.
• Provide immediate feedback to others at any time to reinforce good safety and improvement behaviours and acts.
• Provide coaching for the team members as part of the continuous improvement mindset.
• Role model the behaviours that creates a culture of dignity and respect.
• Responsible for being a designee for the people lead as required
• Lead projects as required

What skills you will need:

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

• A degree qualification in Science/Quality/Technical disciplines.
• Minimum 4 years’ experience in the biotechnology and/or pharmaceutical industry, (preferably both) •
• Leadership skills and experience managing daily activities.
• Preferably Lean Six Sigma experience.
• Excellent written and oral communication skills.
• Strong understanding of cGMP requirements for manufacturing and/or systems and compliance.
• Required to work on their own initiative in a constructive manner in addition to working as part of a team.
• Excellent time management and organisational skills.
• Strong understanding of biochemical and cell biology methodology (ELISA, SDS-Page, Bio-Assays, PCR, and compendial assays, e.g. pH, Appearance, TOC etc) and strong technical skills.
• Strong understanding of GMP, ICH, USP and global compendia regulations and guidance's, particularly as related to analytical method development and validation.
• Experience with continuous quality/process improvement tools (As defined by the site, e.g. DMAIC, Lean QA, 5S etc).
• Excellent trouble shooting and problem solving skills.
• Ability to think logically and be proactive under pressure.
• Flexible and self-motivated.
• Ability to challenge the status quo with a continuous improvement mindset.
• Promoting a culture where diversity and inclusion is part of the DNA

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 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.

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

The Laboratory Operations Leader will provide strategic and operational leadership to the Laboratories to test quality pharmaceutical products in meeting the four Manufacturing Division priorities of: Compliance, Supply, Strategy and Profit Plan.

The Laboratory Operations Leader is responsible to mould the culture to one that supports a High-Performance Organisation.

personal accountability and responsibility, continuous self- development and colleague collaboration in an open and trusting environment where all colleagues are comfortable to voice their opinions The Laboratory Operations Leader is responsible for prioritization of proposed mitigation plans and/or acceptance of Quality Risks identified as part of the Quality Risk Management Process under the remit of decision maker roles and responsibilities (as required)

Primary activities/responsibilities:

• Ensure the highest Compliance standards.
• Ensure supply of high-quality product in line with testing schedules. A Integral Member of the Site Quality leadership team (QLT) and the Site Leadership Team (SLT) on key operational and strategic priorities
• Work as a key member of the Site Extended leadership team (ELT)
• Provide sound financial stewardship, management, and control.
• Lead a cross-functional management team providing ongoing coaching and support, including the identification and development of key talent.
• Drive performance and management of individuals and team.

What Qualifications you will need:

• Degree or 3rd level qualification (Science, Engineering, Quality).
• Desirable project management qualification such as Project
• Management Professional etc.
• Desirable Lean Six Sigma Green belt or higher

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

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.