Pharmaceutical & Biotechnology
QA Manager – South Dublin
- Contract
- South Dublin, County Dublin, Ireland
- 42038403
The Role:
PE Global are recruiting for a QA Sr. Manager to be based in Dun Laoghaire
12 Month initial contract
Description
Quality and Compliance Oversight of a contract lab, CMO or a raw material SME. Alignment with CTA / Marketing Application.
Key Responsibilities
- Be an integral quality member of cross-functional contract manufacturing team that includes but is not limited to business operations, analytical science, process development, supply chain XPD etc.
- Negotiator and Approver of quality agreements
- Lead the preparation of the site for and Represent at product-specific Regulatory Inspections and/or during Notified Body audits of CM Site, as applicable or required.
- Present on topics during inspection demonstrating appropriate behaviors and knowledge of the subject areas
- Review / Approve Master Batch Records
- Quality approver for deviations, change controls, CAPA
- Prepare inspection playbooks
- Identify and mitigate Risk at the CMO or testing Laboratories and/or escalate to management
- Perform Person in Plant activities as required
- APR Data Provider
- Manage Audit commitments to completion
- Perform tactical batch disposition activities in support of lot release
Authority
- Decision to release or Reject batches (Dynamic is different for SREs)
- Decision to approve or reject deviations, Change Control, CAPA
- Decision to approve QAGR
- Provide Quality position on GMP related topics and strategy for the site
- Decision to approve Master batch Records/Raw Material Specifications
Basic Qualifications:
- Doctorate degree & 2 years of directly related experience OR
- Master’s degree & 4 years of directly related experience OR
- Bachelor’s degree & 6 years of directly related experience OR
- Associate’s degree & 10 years of directly related experience OR
- High school diploma / GED & 12 years of directly related experience
Preferred Qualifications:
Preferred Requirements:
- 10 + years biotech or pharmaceutical industry experience
- Additional European Languages – desirable not essential
- Significant Quality experience at Aseptic Manufacturing facilities
- Able to facilitate and influence senior stakeholders and partners
- Able to successfully manage workload and timelines
- Familiarity with basic project management tools
- Ability to negotiate a strategic position after taking feedback from multiple sources
- Strong project management, problem-solving, and analytical skills
- Demonstrated ability to lead cross-functional teams, consistently deliver on-time, and high-quality results
- Collaborates and communicates well with others, able to balance divergent inputs from various stakeholders and drive issue resolution
- Ability to operate in a matrixed or team environment with site, functional, and executive leadership
- Experience driving decision making by using DAI principles
- Experience with the “variation management” process
Interested candidates should submit an updated CV.
Please click the link below to apply, call Audrey Mccarthy on +353 21 4297900 or alternatively send an up to date CV to audrey.mccarthy@peglobal.net
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