* Associate QA Manager - Athlone, Ireland (Flexi working option)
* 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.
Due to continued success and growth, PPD is currently looking to
recruit an Associate QA Manager to be based in our GMP Lab in Athlone,
Ireland. The role of Associate QA Manager within the Lab is to ensure
the quality of lab data and reports. This is achieved through various
audits of data and reports as specified by Standard Operating
Procedures and by conducting inspections of Lab procedures.
* DUTIES & RESPONSIBILITIES:
* * Manages the day-to-day operations of a QA team and provides
oversight, development and performance management to staff
* Assesses priority of projects and monitors work assignments ensuring
adequate resourcing to meet client project timelines and provides
quality deliverables
* Assists senior management in the evaluation of QA programs to help
maintain regulatory compliance and efficiency of QA audits
* Evaluates audit and inspection findings produced by QA staff and
determines appropriate departmental interpretation. Identifies issues
that may require follow-up inspection. Reports findings to staff and
senior management
* Participates in client and regulatory inspections in order to
provide information regarding the QA program and facilitates responses
* Identify process improvements
* Consult on OOS and deviations in processes
* 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
* QUALIFICATIONS:
* * Education and Experience
* * Bachelor&#**Apply on the website**;s degree in Science
* Min. 5 years&#**Apply on the website**; experience in a GMP
laboratory-based environment.
* QA experience of:
Quality systems, Scientific data review, Internal audits (Facilities
and Process).
* Knowledge of equipment qualification review, qualification documents
(IQ, OQ, PQ) and validation is advantageous
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&#**Apply on the website**;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 **Apply on the website** days
* Medical Health care cover
* Life Insurance
* We have a strong will to win - We earn our customer&#**Apply on the
website**;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&#**Apply on the website**;s most urgent health needs,
then please submit your application - we&#**Apply on the website**;d
love to hear from you.
As we are likely to receive many applications, sometimes we are unable
to provide feedback to everyone.
#LI-MG1 Position: ?Associate QA Manager ?Flexi working option)
* Associate QA Manager - Athlone, Ireland (Flexi working option)
* 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.
Due to continued success and growth, PPD is currently looking to
recruit an Associate QA Manager to be based in our GMP Lab in Athlone,
Ireland. The role of Associate QA Manager within the Lab is to ensure
the quality of lab data and reports. This is achieved through various
audits of data and reports as specified by Standard Operating
Procedures and by conducting inspections of Lab procedures.
* DUTIES & RESPONSIBILITIES:
* * Manages the day-to-day operations of a QA team and provides
oversight, development and performance management to staff
* Assesses priority of projects and monitors work assignments ensuring
adequate resourcing to meet client project timelines and provides
quality deliverables
* Assists senior management in the evaluation of QA programs to help
maintain regulatory compliance and efficiency of QA audits
* Evaluates audit and inspection findings produced by QA staff and
determines appropriate departmental interpretation. Identifies issues
that may require follow-up inspection. Reports findings to staff and
senior management
* Participates in client and regulatory inspections in order to
provide information regarding the QA program and facilitates responses
* Identify process improvements
* Consult on OOS and deviations in processes
* 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
* QUALIFICATIONS:
* * Education and Experience
* * Bachelor&#**Apply on the website**;s degree in Science
* Min. 5 years&#**Apply on the website**; experience in a GMP
laboratory-based environment.
* QA experience of:
Quality systems, Scientific data review, Internal audits (Facilities
and Process).
* Knowledge of equipment qualification review, qualification documents
(IQ, OQ, PQ) and validation is advantageous
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&#**Apply on the website**;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 **Apply on the website** days
* Medical Health care cover
* Life Insurance
* We have a strong will to win - We earn our customer&#**Apply on the
website**;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&#**Apply on the website**;s most urgent health needs,
then please submit your application - we&#**Apply on the website**;d
love to hear from you.
As we are likely to receive many applications, sometimes we are unable
to provide feedback to everyone.
#LI-MG1
We need : English (Good)
Type: Permanent
Payment:
Category: Others
