Quality Assurance Lead
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| Job Type | Permanent |
| Area | Dublin, Ireland |
| Sector | QualityOperations & Manufacturing |
| Start Date | |
| Advertiser | Ashling Guthrie |
| Job Ref | #2079 |
| Job Views | 168 |
- Description
- We have a permanent opening available for a Quality Assurance Lead at our Clients API manufacturing facility in Dublin. This is a key role in the Quality Department providing QA support to both manufacture operations for API and to laboratory operations for API and drug product testing. You will take responsibility and ownership for management of the site Quality Management System. It will involve batch documentation review and interaction with third party suppliers, and will ensure adherence with regulatory and best practice requirements while delivering consistently for the internal and external customer
Why you should apply:
The company is dedicated to diversity and inclusion and diversity, a culture empowering all people.
A global focus, ensuring continuous investment in people and portfolio.
They are an industry leader with a start-up mentality, but long history spanning more than 150 years.
What you will be doing:
Principal business owner for site OMS, Responsible for owning and maintaining
Manage, motivate and develop the QA team
Build and maintain strong cross functional relationships across the site
Responsible for supporting analytical method transfer, ongoing testing and stability program through review of associated documentation
Review release and stability specifications for raw materials, API and drug product. To propose and revise specifications as necessary.
Review and approve analytical data to raw materials, support API and drug product manufacturing, testing, stability and release.
To ensure customer satisfaction through continuous improvement & RFT
Prepare, review and approve documentation, SOP’s, trending, metrics, training etc.
To ensure the OMS is cGMP compliant and audit ready
Ensure that any change controls and any formal investigations are conducted promptly and thoroughly.
Keep up to date with compliance and regulatory guidance
Lead and/or partner for the Annual Product Review process and lead in regulatory audits on QA aspects.
To ensure Key Performance Indicators are known, promoted and achieved
To ensure Staff are appropriately trained and there is an appropriate level of cross training for activities and responsibilities within the team.
To ensure compliance with all EHSS site procedures
Ownership and accountability for all Quality aspects related to the role in support of patient need and regulatory compliance.
What you need to apply:
Bachelor's Degree in scientific discipline preferred plus 8+ years' experience working within the Quality Department in a Pharmaceutical Manufacturing Facility.
Self-motivated and self-managing.
Able to identify, execute and prioritize work/projects and escalate when required
Good interpersonal skills are required, as is the ability to communicate well, both verbally and written.
Ability to use leadership skills to positively manage issues.
Ability to coach and train staff in their team.
Self-motivated and self-managing. Able to identify, execute and prioritize work tasks/projects with an awareness of escalation responsibility as needed.
Critical problem-solving skills.
Demonstrated data driven decision-making ability.
Good computer skills, including proficiency with business and technical software (Word, Excel, PowerPoint, Project, Empower, Tiamo, SAP, LIMS).
Ability to plan, organize, and prioritize projects to schedule.
Excellent technical and- compliance-based writing skills.
