Job Details: QA Manager GCP/Clinical


JobsIreland
Jervis Street
Dublin 1
QA Manager GCP/Clinical
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

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