QA Validation Associate

Desired Skills: cGMP,equipment,Utility Validation

PE Global is currently recruiting for a QA Validation Associate for a leading multi-national Biotech client based in X.

This is an initial 12-month contract position responsible for the quality oversight of validation activities in a GMP regulated environment, incorporating implementation, requalification and decommissioning of manufacturing processes, equipment, computer systems, laboratory systems and changes to existing equipment.

ROLE:

• Provide quality oversight for validation activities related to the client’s products and facilities, utilities, equipment (FUE).
• Support the development of validation plans for specific system implementation projects.
• Supporting and reviewing/approving (project lifecycle documentation (URS, RA, Commissioning, Qualification Protocols)) validation activities related to the implementation of facilities, utilities, equipment changes while exercising judgment within broadly defined procedures and practices to establish approval criteria, and identify and implement solutions.
• Support validation policies, through development, generation and implementation of validation master plans, guideline documents and SOP’s.
• Maintain current knowledge of industry standards and regulatory requirements for products developed or manufactured by client, validation techniques/approaches and systems utilized at site.
• Lead and represent QA Validation in multi-departmental meetings & project teams.
• Identifies and implements improvements to the QA Validation systems.
• Participation in the change control program for modifications to qualified systems.
• Quality oversight for the Revalidation Evaluation program.
• Identify, track and resolve issues through robust root cause analysis in a timely manner working with relevant SMEs as required. Apply a risk management approach to identify, categorise, prioritise, mitigate and establish contingency plans associated with qualification / validation and system risks

REQUIREMENTS:

• Bachelor of Sciences degree, or higher, in a technical discipline (physical, engineering, chemical or biological sciences) is required.
• +3 years’ experience in a cGMP regulated manufacturing environment, with knowledge of equipment and utility validation, and laboratory systems / validation.
• Organizational and management skills to coordinate multi-discipline project groups
• Ability to speak, present data, and defend approaches in front of audiences and inspectors.
• Ability to comprehend technical information related to equipment, processes, and regulatory expectations.
• Experience with participation in regulatory inspections presenting or defending departmental functions in audits or regulatory inspections.
• Understanding and familiarity with FDA & European regulatory requirements, guidelines, and recommendations for equipment validation expectations.
• Proficiency with technical summary report generation required, with exceptional organizational, spelling, grammar, and typing skills preferred.

Interested candidates should submit an updated CV.

Please click the link below to apply, call Seán on +353 86 3514962 or alternatively send an up-to-date CV to sean.molloy@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***