Associate Compliance Specialist - Athlone, Ireland
We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients.
The role of Associate Compliance Specialist is to provide quality expertise in areas such as root cause analysis, corrective action/preventive action, batch record review.
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.
- 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.
Experience and Qualifications:
- 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).
- 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/workload
As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD truly value a work-life balance. We’ve grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organisation but with a local feel.
- Pension scheme
- Annual Leave 25 days
- Medical Health care cover
- Life Insurance
We have a strong will to win - We earn our customer’s trust - We are gamechangers - We do the right thing -We are one PPD -
If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application – we’d love to hear from you. 1
As we are likely to receive many applications, sometimes we are unable to provide feedback to everyone.