QC Reviewers, 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.
Our GMP laboratory based in Athlone, Ireland offers fully integrated solutions for product development and analytical development, including analytical testing services in method development, method validation, method transfer, release and stability studies. Our highly qualified GMP lab staff work across our 3 laboratory groups: Biopharm, Small Molecule, and Inhalation.
The role of QC Data Reviewers
is to support our Laboratory teams in ensuring the integrity and quality of laboratory and chromotographic data and reports. This is the perfect job for someone who has strong review experience and is looking to move away from hands on lab duties. Key responsibilities:
Qualifications: Education and experience
- Ensures the quality of laboratory data and reports.
- Reviews chromatographic data and related notebooks as specified by Standard Operating Procedures (SOPs).
- Evaluates data to ensure compliance with analytical methods, client criteria, Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP).
- Performs non-routine and complex analytical data reviews ensuring scientific soundness and method validation.
- Reviews sample results tables and analytical reports for completeness and accurate representation of the data and report findings.
- Communicates with laboratory staff to proactively address the quality of laboratory documentation.
- Prepares QC statements noting deficiencies with the analytical data set or notebooks.
- Reports deficiencies to the project leader for correction.
- Trains new QC Reviewers and laboratory staff. Performs other duties as assigned, including SOP review and writing.
- Conducts consultations for quality records.
- BSc in Science or related field required
- 2+ years of QA/QC experience required (gaining thorough knowledge of chromatography)
- Thorough knowledge of SOPs and Federal Regulations to include GLP and GMP
- Strong verbal and written communication skills
- Strong technical knowledge including an understanding of laboratory procedures, methodology and standards
- Ability to independently review laboratory reports and analytical methods
- Strong attention to detail
- Ability to provide clear and concise feedback and/or documentation of results
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.
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 -
- Joining Bonus
- Pension scheme
- Annual Leave 25 days
- Medical Health care cover
- Life Insurance
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.