Senior QC Data Reviewer (Pharma)

Senior QC Data Reviewer (Pharma)

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: toimprove health .You will be joining a trulycollaborative and winning culture as we strive to bend the time and cost curve of deliveringlife-saving therapies to patients.

Envision a workplace where you have a direct impact on improving health, work alongside expert scientists, use newest technologies and collaborate with industry thought leaders and therapeutic experts. Welcome to PPD® Laboratories, where science is our passion, quality is our commitment and people are the cornerstone of our success.

Our team is expanding and we are looking to hire a Senior QC Data Reviewer who will support our analytical team in our GMP Laboratory in Athlone.

As Senior QC Data Reviewer you will monitor the quality of laboratory data and reports, chromatographic data and related notebooks as specified by Standard Operating Procedures.

Responsibilities: Performs complex analytical data review, evaluating laboratory data for compliance with analytical methods, SOPs, directives and scientific soundness. Validates large and/or non-routine projects. Performs analytical data review of method qualification and validation interpreting data for compliance and technical soundness Reviews sample results for completeness and accurate representation of the data and reports 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 Conducts SOP review and writing. Conducts consultations for quality records Assists the departmental manager or supervisor in the evaluation of the laboratory QC program Performs other duties as assigned

Senior QC Data Reviewer (Pharma)

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: toimprove health .You will be joining a trulycollaborative and winning culture as we strive to bend the time and cost curve of deliveringlife-saving therapies to patients.

Envision a workplace where you have a direct impact on improving health, work alongside expert scientists, use newest technologies and collaborate with industry thought leaders and therapeutic experts. Welcome to PPD® Laboratories, where science is our passion, quality is our commitment and people are the cornerstone of our success.

Our team is expanding and we are looking to hire a Senior QC Data Reviewer who will support our analytical team in our GMP Laboratory in Athlone.

As Senior QC Data Reviewer you will monitor the quality of laboratory data and reports, chromatographic data and related notebooks as specified by Standard Operating Procedures.

Responsibilities: Performs complex analytical data review, evaluating laboratory data for compliance with analytical methods, SOPs, directives and scientific soundness. Validates large and/or non-routine projects. Performs analytical data review of method qualification and validation interpreting data for compliance and technical soundness Reviews sample results for completeness and accurate representation of the data and reports 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 Conducts SOP review and writing. Conducts consultations for quality records Assists the departmental manager or supervisor in the evaluation of the laboratory QC program Performs other duties as assigned

Education and Experience: Bachelor's degree in Science, Chemistry or equivalent 4 years industry experience 2 year experience in a relevant position that provides the knowledge, skills, and abilities to perform the job Laboratory analytical experience utilising chemistry analytical techniques and reviewing data Experience in Empower, chromatography, HPLC, and dissolution

Knowledge, Skills, and Abilities: Thorough knowledge of chromatography and divisional SOPs Strong technical knowledge including an understanding of laboratory procedures, methodology and standards Strong verbal and written communication skills Strong attention to detail Ability to train staff Ability to independently review laboratory reports and analytical methods Ability to deal with multiple and changing priorities Ability to provide clear and concise feedback and/or documentation of results Ability to work in a collaborative team environment

At PPD we hire the best, develop ourselves and each other, and recognise the power of being one team.We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD you will benefit from anaward-winning learning and development programme , ensuring you reach your potential.

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 haveaflexible 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 aglobal 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 -

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.

#LI-MH1

Education and Experience: Bachelor's degree in Science, Chemistry or equivalent 4 years industry experience 2 year experience in a relevant position that provides the knowledge, skills, and abilities to perform the job Laboratory analytical experience utilising chemistry analytical techniques and reviewing data Experience in Empower, chromatography, HPLC, and dissolution

Knowledge, Skills, and Abilities: Thorough knowledge of chromatography and divisional SOPs Strong technical knowledge including an understanding of laboratory procedures, methodology and standards Strong verbal and written communication skills Strong attention to detail Ability to train staff Ability to independently review laboratory reports and analytical methods Ability to deal with multiple and changing priorities Ability to provide clear and concise feedback and/or documentation of results Ability to work in a collaborative team environment

At PPD we hire the best, develop ourselves and each other, and recognise the power of being one team.We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD you will benefit from anaward-winning learning and development programme , ensuring you reach your potential.

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 haveaflexible 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 aglobal 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 -

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.

#LI-MH1