Location: Europe, Middle East & Africa-Ireland-Westmeath-Ath
Closing Date: 13 Dec 16
Type: Full Time
Salary (£): On Application
Our Athlone cGMP laboratory offers fully integrated solutions for product development and analytical development, including analytical testing services in method development and secondary packaging, labelling and storage. About the role 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 to ensure the quality of lab data and reports. ...
Our Athlone cGMP laboratory offers fully integrated solutions for product development and analytical development, including analytical testing services in method development and secondary packaging, labelling and storage.
About the role
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 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 and Responsibilities:
Conducts and/or assists a variety of client, internal or GMP audits and regulatory inspections as requested by senior management
Performs directed site audits, and facility audits.
Supports senior management for vendor and/or sub-contractor audits
Participates/leads process audits and may participate as a co-auditor in more complex system audits
Audits laboratory data for compliance with methods and standard operating procedures and report findings
Audits sample result tables and analytical reports for completeness and accurate representation of the data and report findings
Serves as a resources to operational departments on audit or quality assurance
Prepares and presents audit findings and/or other related information at departmental, internal operations or client meetings
Education and Experience
Bachelor's degree or equivalent and relevant formal academic / vocational qualification
Previous Lab experience and QA experience that provides the knowledge, skills, and abilities to perform the job
Knowledge, Skills and Abilities:
Thorough knowledge of GMP and appropriate regional research regulations and guidelines
Demonstrated proficiency and led a range of project based or internal GMP audits and vendor 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
Above average negotiation and conflict management skills
Flexible and able to multi-task and prioritize competing demands/work load
Perform QA audits of facility records and issue written audits. Records include: Equipment maintenance and calibration work, new or relocated equipment qualification documents (IQ/OQ/PQ), and software validation.
The successful candidate can look forward to job stability with a leading CRO that has experienced year-on-year growth. With future expansion plans, there is the opportunity to progress in your career with PPD at our Athlone labs. We offer a generous salary along with private medical insurance, pension and life insurance.
We look forward to receiving your application.
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