QA Auditor

Quality Auditor - Athlone, Ireland - 172328

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 trulycollaborative and winning culture as we strive to bend the time and cost curve of deliveringlife-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.

Due to continued success and growth, PPD is currently looking to recruit a QA Auditor to be based in our cGMP Lab in Athlone, Ireland.The role of QA Auditor within the Lab is toensure the quality of lab data and reports. This isachieved throughvarious audits of data and reports as specified by Standard Operating Procedures and by conducting inspections ofLab procedures.

Duties and Responsibilities: Conducts and/or assists a variety of client, internal or GMP audits and regulatory inspections as requested by senior management Leads process audits and internal audits Participate as a co-auditor in more complex system audits Identify process improvements Identify OOS and deviations in processes Responsible for investigations and non-confirmation reviews of deviations Perform equipment and facility qualification review

Audits laboratory data for compliance with methods and standard operating procedures and report findings Serves as resources to operational departments on audit or quality assurance subject matter Prepares and presents audit findings and/or other related information at departmental, internal operations or client meetings

Quality Auditor - Athlone, Ireland - 172328

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 trulycollaborative and winning culture as we strive to bend the time and cost curve of deliveringlife-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.

Due to continued success and growth, PPD is currently looking to recruit a QA Auditor to be based in our cGMP Lab in Athlone, Ireland.The role of QA Auditor within the Lab is toensure the quality of lab data and reports. This isachieved throughvarious audits of data and reports as specified by Standard Operating Procedures and by conducting inspections ofLab procedures.

Duties and Responsibilities: Conducts and/or assists a variety of client, internal or GMP audits and regulatory inspections as requested by senior management Leads process audits and internal audits Participate as a co-auditor in more complex system audits Identify process improvements Identify OOS and deviations in processes Responsible for investigations and non-confirmation reviews of deviations Perform equipment and facility qualification review

Audits laboratory data for compliance with methods and standard operating procedures and report findings Serves as resources to operational departments on audit or quality assurance subject matter Prepares and presents audit findings and/or other related information at departmental, internal operations or client meetings

Education and Experience Bachelor's degree in Science Min. 2 experience in a lab based environment, with QA responsibility QA experience should include process audits, audits of facilities, equipment qualification review, qualification documents (IQ, OQ, PQ) and validation.

Knowledge, Skills and Abilities: Thorough knowledge of GMP and appropriate regional research regulations and guidelines Demonstrated proficiency and led a range of project/process based or internal GMP audits to high standards required by management Excellent oral and written communication skills Strong problem solving, risk assessment and impact analysis abilities Solid experience in root cause analysis Flexible and able to multi-task and prioritize competing demands/work load

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 an award-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 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 game changers - 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.

Education and Experience Bachelor's degree in Science Min. 2 experience in a lab based environment, with QA responsibility QA experience should include process audits, audits of facilities, equipment qualification review, qualification documents (IQ, OQ, PQ) and validation.

Knowledge, Skills and Abilities: Thorough knowledge of GMP and appropriate regional research regulations and guidelines Demonstrated proficiency and led a range of project/process based or internal GMP audits to high standards required by management Excellent oral and written communication skills Strong problem solving, risk assessment and impact analysis abilities Solid experience in root cause analysis Flexible and able to multi-task and prioritize competing demands/work load

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 an award-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 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 game changers - 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.