MSD QA Validation Specialist 

Ireland 

813133056

Job Description

Quality Assurance, Validation Specialistat our R&D facility in Dunboyne. You will support new Validation and Commissioning programs across site as well as the periodic review of validated systems within the Drug Substance, Facilities, and laboratories to ensure ongoing compliance to current Good Laboratory Practices (cGLP) and current Good Manufacturing Practices (cGMP).

This role will be key in supporting the day to day running of the Validation dept, Laboratories and Projects to ensure that processes are streamlined, and business objectives adhered to. You will be the key in driving QA compliance to ensure standards are best in class across our industry, a benchmark for others to aspire to. You will support the specialist role function in each area.

What you will do:

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

• Collaborate with sustaining and project based teams; GES, Validation, Microbiology, QC and other departments to provide QA support for commissioning, decommissioning and Validation project across site.
• Responsible for the approval of commissioning and Validation protocols and reports supporting the introduction of new laboratory and process equipment.
• Provide real time review of commissioning test scripts, Protocols and escalate issues in a timely manner to CQV and QA leadership as appropriate.
• Act as Quality Assurance point of contact for EMPQ, Cleaning Validation, Utilities, Temperature mapping and PQ of process equipment.
• Workas directed by the Quality Assurance Validation lead according to company safety policies, cGMP and cGLP.
• Champion rollout of Data Integrity Culture across site.
• Working Knowledge of GMP regulatory guidelines with the ability to accurately interpret and provide quality guidance for validation activities in the drug substance and laboratory areas.
• Acts as the site Quality Point of contact with external and COE groups to define and implement new technical standards on site for existing, new technologies and equipment.
• Any other tasks as directed by QA Validation Lead.

What skills you will need:

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

• Min of a BSc Degree in relevant Science
• Min. 3 year Validation / CQV / CSV experience
• Change Control and Deviation management experience.
• Problem solving Techniques.
• Knowledge of cGMP & Laboratory Quality Systems.
• Experience and critical skills in the area of expertise that add value to the business, ideally CSV, Process Validation, Temperature mapping.
• KNEAT (eVAL), Cleaning Validation, Environmental Monitoring, Filter Validation studies and Single use equipment as distinct advantage.
• Knowledge of regulatory requirements to Irish, European and International Codes,
• Standards and Practices.
• Report, standards, technical writing skills required.
• Lean Six Sigma Methodology experience.
• Effective communication, presentation and interpersonal skills, to interface effectively with all levels of colleagues and with external customers in a team orientated manner.
• Ability to work independently

Please feel free to speak to us about what flexibility means to you during your application or click on the link to find out more about our hybrid working model.

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.

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