Quality Assuranace Engineer

Role:

The Quality Engineer position will be responsible, with management support, for providing oversight of quality activities associated with Engineering, Automation and Validation activities at ADMF. This responsibility includes the oversight of the College Park QMS to ensure that quality and compliance requirements are followed in line with business needs. Experience as a Quality Engineer who has been part of New Product Introduction projects would be beneficial.

Key Responsibilities:

● Responsible for Quality oversight, with management support of Engineering, Automation and Validation at College Park.
● Quality Oversight on new product introduction in Bulk Drug Substance facility.
● Provide QA support for risk-based verification activities in the capacity of Quality Assurance Subject Matter Expert. Review and approval equipment/utilities verification documentation from design to post execution.
● Review and Approve project documents involving cross-functional, multi-departmental teams including: Operations, Process Engineering, Quality Control, Quality Assurance, Facilities, and others. ● Participate in verification quality risk assessments and provide quality oversight to ensure verification quality risk assessments are effectively maintained/controlled.
● Review and approval of validation documents for equipment, software and equipment qualifications, and others. (e.g. URS, Facility, Utility, IT Systems, Test Method, and Equipment validations) to ensure compliance with current regulatory expectations, EU, FDA and Corporate Standards and Internal Procedures.
● Investigation and approval of deviations generated encountered during qualification/validation testing.
● Participation in the project change control program and deviations for modifications to new and existing equipment.
● Provide quality oversight of on-site engineering controls including calibration and preventative maintenance programs.
● Performs timely review of documentation/investigations/reports highlighting and assisting in the resolution of issues commensurate with the level of risk
● Ensures schedules for review and approval of GMP documents are maintained to meet the needs of Commercial Operations groups.
● Provide sound QA and Compliance support to manufacturing, engineering, utilities, supply chain and material movement.
● Provide support for deviation investigations, including root cause analysis, and corrective & preventative action (CAPAs) proposals and initiatives.

Requirements:

● A minimum of 5 years relevant experience within the pharma industry or a related field.
● Minimum 3 years of experience in QA technical role. Sound awareness and understanding of pharmaceutical business, especially with regards to quality and regulatory requirements.
● Strong knowledge of cGMP requirements for pharmaceutical manufacturing and/or packaging required.
● Experience of sterility assurance for drug products and in manufacturing processes for pharmaceutical products and processes strongly desirable.
● Excellent accuracy and attention to detail
● Good knowledge of relevant computer packages e.g. TrackWise or similar
● Planning and organizing skills are required to plan, execute and track commitments of Quality Assurance and to adjust to changing priorities.
● High level technical skills including analytical, auditing, pharmaceutical manufacturing and regulatory inspection management. Technical writing skills required.

Interested candidates should submit an updated CV.

Please click the link below to apply, call William Cunnage on +353 21 4297900 or alternatively send an up-to-date CV to William.Cunnage@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***