currently recruiting for a Quality Assurance Executive.
The QA Executive will be responsible for:
? Maintain and develop the Quality Management System (QMS) in
accordance with relevant regulatory requirements and business need
? Implement an effective Quality Assurance process, including
internal and external audit programs, and ensure timely completion of
audits
? Lead the quality oversight process on outsourced activities, which
includes; o Developing and maintaining Technical Agreements with
vendors in line with relevant regulatory and business requirements o
Performance of onsite audits as required - vendors / clinical sites o
Analysis and reporting of Key Performance Indicators (KPIs)
? Oversee the effective documentation and tracking of QMS
activities, including deviations and change controls, and the
implementation of corrective actions.
? Provide quality leadership and support to operational teams,
including the review of batch records, technical reports and clinical
trial protocols
? Manage the Documentation Control process, ensuring that policies
and procedures are up to date, and available to all relevant parties
? Ensure that all activities are conducted in compliance with the
requirements of relevant GxP guidelines.
? Contribute to Company Training procedures as required
? Carry out various other additional tasks that may be required from
time to time in accordance with the overall goals of the company
Requirements:
? Scientific degree
? At least 3 years GxP experience in the pharmaceutical/biotech
industry
? QA auditing experience
? Knowledge of relevant regulatory requirements
? Excellent interpersonal, communication, and problem solving skills
? Strong computer skills
? Flexible in reacting to changing priorities in a dynamic business
environment.
? Ability to travel as required
For more information and to apply for this role please call Linda on 1
or e-mail
Thornshaw Scientific Recruitment is a leading Irish provider of
specialist Scientific Recruitment. Part of the CPL Group. Tel: 1 On behalf of our client, a biopharmaceutical company, we are
currently recruiting for a Quality Assurance Executive.
The QA Executive will be responsible for:
? Maintain and develop the Quality Management System (QMS) in
accordance with relevant regulatory requirements and business need
? Implement an effective Quality Assurance process, including
internal and external audit programs, and ensure timely completion of
audits
? Lead the quality oversight process on outsourced activities, which
includes; o Developing and maintaining Technical Agreements with
vendors in line with relevant regulatory and business requirements o
Performance of onsite audits as required - vendors / clinical sites o
Analysis and reporting of Key Performance Indicators (KPIs)
? Oversee the effective documentation and tracking of QMS
activities, including deviations and change controls, and the
implementation of corrective actions.
? Provide quality leadership and support to operational teams,
including the review of batch records, technical reports and clinical
trial protocols
? Manage the Documentation Control process, ensuring that policies
and procedures are up to date, and available to all relevant parties
? Ensure that all activities are conducted in compliance with the
requirements of relevant GxP guidelines.
? Contribute to Company Training procedures as required
? Carry out various other additional tasks that may be required from
time to time in accordance with the overall goals of the company
Requirements:
? Scientific degree
? At least 3 years GxP experience in the pharmaceutical/biotech
industry
? QA auditing experience
? Knowledge of relevant regulatory requirements
? Excellent interpersonal, communication, and problem solving skills
? Strong computer skills
? Flexible in reacting to changing priorities in a dynamic business
environment.
? Ability to travel as required
For more information and to apply for this role please call Linda on 1
or e-mail
Thornshaw Scientific Recruitment is a leading Irish provider of
specialist Scientific Recruitment. Part of the CPL Group. Tel: 1
We need : English (Good)
Type: Permanent
Payment:
Category: Others
