Validation Analyst

Pharmaceutical Product Development (PPD)

IE-Athlone-Athlone IE Business & Tech Pk


Validation Analyst – Athlone, Ireland

We are vital links between an idea for a new medicine and the people who need it.

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.

Rapid growth of our GMP Laboratory has created new opportunities for computer system validation professionals in Athlone, Ireland. Our validation team plays an integral role in our mission by ensuring new laboratory systems are tested, deployed, and supported in a manner consistent with internal SOPs and external regulations. The role requires you to devise test strategies and drive the execution of testing to provide evidence of requirements coverage and traceability.

The role as a Validation Analyst at PPD, provides a unique opportunity to gain a further understanding in the fundamentals of software development life cycle, including preparation of systems for GxP use. Knowledge and use of the following skills is required:

Key responsibilities: User requirement specifications Installation and Operational Qualification/Performance Qualification GAMP 21 CFR Part 11 and/or Annex 11 Data integrity Investigating, documenting and communicating software defects. Maintaining broad awareness of efforts within groups to assure technical quality excellence, accurate execution, and appropriate use of resources. Developing new and improving existing Standard Operating Procedures Prior experience in software validation is required for this role

Validation Analyst – Athlone, Ireland

We are vital links between an idea for a new medicine and the people who need it.

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.

Rapid growth of our GMP Laboratory has created new opportunities for computer system validation professionals in Athlone, Ireland. Our validation team plays an integral role in our mission by ensuring new laboratory systems are tested, deployed, and supported in a manner consistent with internal SOPs and external regulations. The role requires you to devise test strategies and drive the execution of testing to provide evidence of requirements coverage and traceability.

The role as a Validation Analyst at PPD, provides a unique opportunity to gain a further understanding in the fundamentals of software development life cycle, including preparation of systems for GxP use. Knowledge and use of the following skills is required:

Key responsibilities: User requirement specifications Installation and Operational Qualification/Performance Qualification GAMP 21 CFR Part 11 and/or Annex 11 Data integrity Investigating, documenting and communicating software defects. Maintaining broad awareness of efforts within groups to assure technical quality excellence, accurate execution, and appropriate use of resources. Developing new and improving existing Standard Operating Procedures Prior experience in software validation is required for this role

Qualifications

acBachelor's degree or equivalent and relevant formal academic / vocational

quQualification.

PrPrevious experience that provides the knowledge, skills, and abilities to perform the job ( comparable to 2 years).

Key Experience Attention to detail and problem-solving skills Client focused approach with strong interpersonal skills Strong oral and written communication skills Competent with MS Word, MS Excel, MS PowerPoint, MS Project Demonstrates positive attitude, enthusiasm toward work and the ability to work well with others Good organization skills and time management skills with the ability to adapt and adjust to changing priorities and to manage multiple assignments with challenging/conflicting deadlines Ability to learn new computer software with minimum of instruction Strong troubleshooting skills needed to analyze software defects and the ability to explain how errors are produced Ability to draft and review and critique documentation including Requirements, Functional Design, System Design, and Test Plans Ability to assess the cause of test failures

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 gamechangers - We do the right thing -We are one PPD -

Qualifications

acBachelor's degree or equivalent and relevant formal academic / vocational

quQualification.

PrPrevious experience that provides the knowledge, skills, and abilities to perform the job ( comparable to 2 years).

Key Experience Attention to detail and problem-solving skills Client focused approach with strong interpersonal skills Strong oral and written communication skills Competent with MS Word, MS Excel, MS PowerPoint, MS Project Demonstrates positive attitude, enthusiasm toward work and the ability to work well with others Good organization skills and time management skills with the ability to adapt and adjust to changing priorities and to manage multiple assignments with challenging/conflicting deadlines Ability to learn new computer software with minimum of instruction Strong troubleshooting skills needed to analyze software defects and the ability to explain how errors are produced Ability to draft and review and critique documentation including Requirements, Functional Design, System Design, and Test Plans Ability to assess the cause of test failures

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 gamechangers - We do the right thing -We are one PPD -


2020-06-23 00:00:00


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