Job Reference: FRS56269
Job Duration:
Start date:
Description:
Quality Assurance Manager
I am delighted to be supporting my client, a leading and rapidly growing pharmaceutical company based in Waterford in recruiting a Quality Assurance Manager. This company has invested millions into their Waterford facilities including a brand new R&D, sterile fill finish and Packaging Facility which shows their long-term commitment to employees and the area. They pride themselves in recruiting, developing, and retaining the best people as they continue to grow.
This is a superb opportunity to work in for an innovative and friendly pharmaceutical company that serve patients with life-improving treatments. Your work will truly make a difference to people's lives and you will work alongside cutting-edge technology and a supportive and friendly team.
What is my client offering you?
*Permanent position
* Attractive salary and benefits package, including bonus, healthcare, pension etc.
* Opportunity to workon a hybrid working model.
Your new position…
Reporting to the Head of Quality, you will be responsible for managing all Quality Assurance and Quality Systems activities for the company.
Key Responsibilities ( A snapshot…)* Support the Head of Quality with the quality department function
* Maintain the company Pharmaceutical Quality System to include: People, Premises & Equipment, Production, QC, Outsourced activities, Complaints & Product Recall, Self Inspection* Have ownership of deviation procedures and approval of investigations
* Incidents & Deviations & Complaints
* Out-of-Specifications, Out-of-Calibrations, Out-of-Trends
* Planned Changes
* Manage Self Inspection Program
* Manage and facilitate outside Inspections (Customer audits / Regulatory inspections)
* Manage manufacturing batch documentation review
*Manage Vendor Qualification
* Manage API, Excipients & Packaging Components material disposition
* Manage batch packagepreparation for QP release
* Be responsible for contract manufacturing organization management Batch documentation review ensuring compliance to standards and SOP's - Batch package preparation for QP release - Manage Vendor Qualification - API and excipient disposition - Primary & Secondary component disposition
Key Requirements
* Relevant Third Level Degree - scientific discipline
* Minimum 7 years' experience in the biopharmaceutical/Pharmaceutical industry, 4 of which should be withina Quality function
* Minimum 3 years leadership experience, including team coaching and development
* Experience of QualityAssurance of aseptic medicinal products and in particular biopharmaceuticals.
* Experience in using lean methodologies and /or operating within Value Streams
* Candidate is eligible to act as a Qualified Person as described in EU Directives, would bean advantage
* Experience preparing and hosting Customer & Regulatory Inspections
* Lead auditor experience
* Extensive knowledge of electronic QMS systems - EDMS, ERP, TrackWise etc.
For a confidential discussion and to review the JobDescription Apply Now or contact Kerry on 086 044 3981
Industry: Pharmaceuticals
Salary: Negotiable, Healthcare, pension, bonus,
Salary Benefits: Negotiable, Healthcare, pension, bonus,
Vacancy Type: Permanent
Job Skills: Quality Assurance, Quality Systems, Pharma
Contact Name: Kerry Rickard
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Direct Application URL: -