QA Validation Associate

PE Global (UK); Ringaskiddy; On-site; EUR 50,000 - 70,000; Full time

Job summary

PE Global (UK) is looking for a Quality Oversight Specialist located in Ringaskiddy, County Cork, Ireland. The role involves providing quality oversight for validation activities related to the client’s products and facilities and requires a Bachelor of Sciences degree in a technical discipline. Candidates should have at least 3 years of experience in a cGMP regulated environment, strong organizational and management skills, and the ability to communicate effectively during regulatory inspections.

Qualifications

• 3+ years experience in a cGMP regulated manufacturing environment.
• Ability to present data and defend approaches in audits.
• Proficiency with technical report generation.

Responsibilities

• Provide quality oversight for validation activities related to client’s products.
• Support development of validation plans for system implementation projects.
• Lead QA Validation in multi-departmental meetings.

Skills

Organizational skills

Management skills

Technical comprehension

Regulatory compliance

Communication skills

Education

Bachelor of Sciences degree in a technical discipline

Job description

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.

Our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland.