QA Specialist II

At PPD, we help our client delivers life-changing therapies that address the world’s most challenging health concerns. We hire the best, develop ourselves and each other, and recognize the power of being one team!

Quality Specialist II

The Role of the Quality Specialist II based in Athlone, Co. Westmeath is to provide quality expertise in areas such as root cause analysis, corrective action/preventive action, batch record review, specialized laboratory testing, performance of internal and/or vendor audits, participation in client or regulatory audits, required documentation review/approval, tracking of investigations, deviations or audit responses, the management of corrective and preventive (CAPA) action plans that result, and attendance at inter-departmental meetings related to the area of expertise. Key responsibilities

Serves as subject matter expert for process/vendor audits or activities in area of expertise, e.g. reviews manufacturing investigations, lab investigations, root cause analysis, batch record review or Total Quality Management.

• Participates in client and regulatory inspections/audits, might represent the department, and participates in developing and tracking corrective actions.

• Reviews batch records and associated documentation for completeness and accuracy of data.

• Utilises department checklists to evaluate content of reports and compliance with reporting criteria.

• Verifies accuracy of analytical results and sample identification; inventories and submits data to archives. Provides support for quality investigations and contracted services.

• Handles production pre and post line clearances and in-process checks as per GMP requirements.

• Provides support to the department with incoming material inspection as per GMP requirements.

• Participates in risk assessments.

• Manages set up and filing of documents.

• May mentor junior team members in area(s) of expertise.

At PPD, we help our client delivers life-changing therapies that address the world’s most challenging health concerns. We hire the best, develop ourselves and each other, and recognize the power of being one team!

Quality Specialist II

The Role of the Quality Specialist II based in Athlone, Co. Westmeath is to provide quality expertise in areas such as root cause analysis, corrective action/preventive action, batch record review, specialized laboratory testing, performance of internal and/or vendor audits, participation in client or regulatory audits, required documentation review/approval, tracking of investigations, deviations or audit responses, the management of corrective and preventive (CAPA) action plans that result, and attendance at inter-departmental meetings related to the area of expertise. Key responsibilities

Serves as subject matter expert for process/vendor audits or activities in area of expertise, e.g. reviews manufacturing investigations, lab investigations, root cause analysis, batch record review or Total Quality Management.

• Participates in client and regulatory inspections/audits, might represent the department, and participates in developing and tracking corrective actions.

• Reviews batch records and associated documentation for completeness and accuracy of data.

• Utilises department checklists to evaluate content of reports and compliance with reporting criteria.

• Verifies accuracy of analytical results and sample identification; inventories and submits data to archives. Provides support for quality investigations and contracted services.

• Handles production pre and post line clearances and in-process checks as per GMP requirements.

• Provides support to the department with incoming material inspection as per GMP requirements.

• Participates in risk assessments.

• Manages set up and filing of documents.

• May mentor junior team members in area(s) of expertise.

Key Experience

• Identified expertise in one or more specialized areas relevant to QA activities, e.g. batch record review, root cause analysis, TQM • May require knowledge of QP Release activities • Knowledge of GxP and appropriate regional regulations and guidelines

• Working knowledge of project based or internal GxP audits and vendor audits • Excellent oral and written communication skills

• Strong problem solving, risk assessment and impact analysis abilities • Experience in root cause analysis and CAPA management

• Ability to remain flexible and prioritize competing demands/work load • Ability to multitask whilst still delivering high quality results

Education

Bachelor's degree or equivalent and relevant formal academic / vocational qualification

Previous lab or QA experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2 years).

Competitive SalaryPension schemeMedical Health Insurance and Life InsuranceAnnual leave: 25 days holidayAnnual performance Bonus

Benefits you will enjoy at PPD

The successful candidate can look forward to job stability with a leading CRO that has experienced year-on-year growth. With future expansion plans, there is the opportunity to progress in your career with PPD at our Athlone labs.

Key Experience

• Identified expertise in one or more specialized areas relevant to QA activities, e.g. batch record review, root cause analysis, TQM • May require knowledge of QP Release activities • Knowledge of GxP and appropriate regional regulations and guidelines

• Working knowledge of project based or internal GxP audits and vendor audits • Excellent oral and written communication skills

• Strong problem solving, risk assessment and impact analysis abilities • Experience in root cause analysis and CAPA management

• Ability to remain flexible and prioritize competing demands/work load • Ability to multitask whilst still delivering high quality results

Education

Bachelor's degree or equivalent and relevant formal academic / vocational qualification

Previous lab or QA experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2 years).

Competitive SalaryPension schemeMedical Health Insurance and Life InsuranceAnnual leave: 25 days holidayAnnual performance Bonus

Benefits you will enjoy at PPD

The successful candidate can look forward to job stability with a leading CRO that has experienced year-on-year growth. With future expansion plans, there is the opportunity to progress in your career with PPD at our Athlone labs.