Website Independent Search Solutions Ltd
My client is looking for a Qualified Person (QP) either based in the West of Ireland or looking to relocate.
An established Pharmaceutical firm, they offer some of the best Remuneration Packages in the Market.
You will need to have previously worked in a GMP Environment; either Medical Device or Pharmaceutical and worked as a Qualified Person (QP) for a period of 2 Years or more.
As a Management position within the organization (Quality Manager) you will report to the Director of Quality Assurance and Supervise Members from a range of Teams.
Qualified Person / Quality Manager / Quality Assurance / Quality / QP / QA / Pharmaceutical / Medical Device / GMP / Mayo /Ireland
Job Title: Qualified Person / Quality Manager
Location: Co. Mayo
- Permanent / Full Time
- €-Basic (Dependent on Experience & Open to Negotiation)
- Health Insurance
- Paid Annual Leave
- Relocation Package
The QP will have QA oversight of all activities in the business unit ensuring the necessary GMP requirements are upheld. The QP will hold responsibility for certifying all batches manufactured in the business unit against the requirements of its marketing authorisation and the principles of GMP. The QP is legally responsible for batch disposition and must be listed on the manufacturing authorisations. The role will provide support to the Director of QA in addition to the Business Unit Leader in achieving the required goals and objectives.
- Provide quality input for all activities undertaken within the business unit
- Represent the company in all business unit Ministries of Health inspections, ensuring the unit is audit-ready. Ensure any non-conformances and open commitments related to the business unit are addressed
- The QP will approve all records generated by the business unit, including but not limited to batch records, laboratory certificates of analysis, deviations, validation documents and product quality review reports
- Evaluate and disposition all batches manufactured in the unit
- Provide guidance on all non-conforming material/deviated batches. Direct the investigation and determine the release disposition of such material/product
- Participate in the business unit APEX activities providing quality input
- Direct the activities of the QA and Product release personnel within the business unit to ensure the product is released and activities are undertaken in a compliant manner.
- Third Level Qualification
- 2 Years Previous Experience in a Qualified Person (QP) Role within the Pharmaceutical / Medical Device Sector
- Relationship Building: Establishing excellent working relationships with the Business Unit Planners. Hands on approach and giving clear and concise instruction when required
- Communication: Excellent communication and presentations skills, both written and oral – ability to present forecasting, capacity, and other relevant planning data in a clear and concise manner to the Business Unit Planners and where required, to management
- Planning & Organizing: Able to plan activities and tasks
- Decision Making: Identify and understand issues, problems, and opportunities whilst providing a viable solution
- Adaptability: Able to work in a fast, dynamic, environment whilst being able to adjust readily to meet unexpected constraints
- Passion for Results: Drive, high energy, maturity, and ability to work under pressure and deliver results; get things done (an action-oriented approach); overcome obstacles
If you would like to be considered for this fantastic opportunity why not contact me directly on my mobile 00353 (0) 87 25 35 247; Just ask for Patrick.
Alternatively, follow the links below and send me your CV.
Key Words: Qualified Person / Quality Manager / Quality Assurance / Quality / QP / QA / Pharmaceutical / Medical Device / GMP / Mayo /Ireland
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To apply for this job please visit independentsearchsolutions.com.