QA Validation Specialist

Desired Skills: quality assurance,validation,CQV

The role:

PE Global is currently recruiting for a QA Validation Specialist on behalf of a leading pharmaceutical company based in Dundalk. This is an initial 11 month contract role.

Overview:

A fantastic opportunity has arisen for a Quality Assurance, Validation Specialist. 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 cGLP and cGMP.

You will support the specialist role function in each area. Bring energy, knowledge, innovation to carry out the following: Work as directed by the Quality Assurance Validation lead according to company safety policies, cGMP and cGLP.

Responsibilities:

• Collaborate with project-based teams, Validation, Microbiology, IT, Engineering utilities and other departments to provide QA support for commissioning, decommissioning and Validation project across site.
• Responsible for the approval of Validation Lifecycle documents and reports supporting the introduction of new laboratory and process equipment.
• Responsible for the approval of Validation Lifecycle documents and reports supporting Temperature mapping, EMPQ and AVS studies
• Provide Quality oversight of Periodic review and Equipment revalidation.
• Provide real time review of commissioning test scripts and escalate issues in a timely manner to CQV and QA leadership as appropriate.
• Support the Site Calibration program
• Act as Quality Assurance point of contact for Cleaning Validation, WFI PQ, and PQ of process equipment including Filter Integrity, parts washers, Autoclaves and process Validation studies, etc.
• Act as a Champion for developing a 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
• Any other tasks as directed by QA Validation Lead.

Education and Experience:

• Min of a BSc Degree in relevant Science. MSc preferable.
• 1 year Validation / CQV experience.
• Experience and expertise that add value to the business; Chemistry, Chemical Eng, Biological science, Biotechnology in a Biopharmaceutical GMP setting.
• Knowledge of cGMP Process & utility Quality Systems.
• Knowledge of Deviation management, Change Management, Risk Management.
• KNEAT, Cleaning Validation, Environmental Monitoring, Filter Validation studies and Single use equipment as distinct advantage.
• Knowledge of regulatory guidelines supporting Drug substance manufacturing: ICH, EU and FDA.
• Strong technical writing skills required.
• 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 in a high-paced team environment, meet deadlines, and prioritize work from multiple projects. Ability to work with management locally and globally.

Interested candidates should submit an updated CV.

Please click the link below to apply, call Kellie on 0214297900 or alternatively send an up to date CV to kellie.hackett@peglobal.net

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***