Quality Assurance Manager

Job Title: Quality Assurance Manager
Contract Type: Contract
REF: 122845
Contact Name: Laurentina Kennedy
Contact Email: laurentina@rftgroup.ie
Job Published: over 5 years ago

Job Description

Quality Assurance Manager
The QA Manager will be responsible for developing and maintaining Quality Systems and Vendor Management activities

The QA Manager is responsible for monitoring and supporting the quality performance of contract manufacturing organisations (CMOs) and material/service suppliers to ensure that all operations are fully in compliance with current international standards for cGMP. Specifically, this position is responsible for Quality oversight of CMOs/vendors of Investigational Medicinal Product, used in sponsored clinical studies in support of new product introduction and existing product development during lifecycle management.
Lead and/or support quality oversight of GxP contractors as required including manufacturing, analytical testing, packaging and distribution. Monitor daily operations at the contract site including batch review and disposition, review of stability data, deviations, OOS investigations, change controls, complaints and other quality systems.
Oversight of non-routine manufacturing/packaging activities at the contractor site.
Work with and ensure compliance with the GxP vendor qualification programme including initial and ongoing qualification to ensure quality oversight of GxP Vendors.
Act as the lead auditor in third party vendor audits as per the audit schedule.
Be a key member of company audit team during regulatory or customer audits.
Support the execution of the internal Quality Management System (QMS) to ensure compliance with all relevant standards within the company, including, but not limited to Product Complaints, Deviation & CAPA, Out-of-Specification Investigations, Change Control, Product release for distribution, Internal Audit, SOPs and Controlled Documents, Training, Artwork approval, Validation and qualification.
Contribute to the development of quality policies and procedures and participate in the internal audit programme, which serves to verify adherence to and compliance with the requirements set out in these controlled documents.
Provide QA and technical support to key company pre-and post-approval development activities such as Manufacturing site transfers and process scale-up; Product life cycle maintenance activities and new product launch; Analytical method qualification & method transfer; Integration activities following product acquisition and Product formulation development.
Build authentic relationships and lead business meetings and audits of critical suppliers and contract manufacturers and maintain all product-related Quality Technical Agreements (QTA's).

Professional Competencies:
Bachelor's degree in chemistry, biology, pharmacy or a related discipline. An advanced degree in pharmaceutical science desirable.
Significant experience (5-10 years) working in finished product pharmaceutical/biologics, including validation, analytical chemistry, quality assurance, quality control, development, and /or manufacturing areas.
Eligibility to act as a licensed Qualified Person is extremely desirable.

For further information on this QA Manager position please contact Laurentina Kennedy at The RFT Group on 01 2302400 Check out all our open jobs on our Recruitment website: www.rftgroup.ie
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