Our client, a Multinational Biopharmaceutical company, are currently seeking an experienced and proactive Qualified Person to support their operation in their Cork facility.
This is a 12-month contract role based onsite in Cork.
Responsibilities:
- Complies with the responsibilities of Qualified Person (QP) stated in directives issued by EC to Certify Batch Releases for sale or supply in compliance with regulations.
- Responsible for change control, non-conformities, and CAPAs.
- Participate in Internal & External Audits.
- Own, review, and approve SOP's and other GDP/cGMP documentation and records.
- Validate the primary manufacturing and testing processes.
- Provide QP support to quality related issues, as the need arises.
- Participate in cross-functional teams as Quality / QP representative.
- When required, serve as a lead/coordinator of investigations and CAPA recommendations related to manufactured products.
- Works with Research and Development during new product start-ups and establishes key checkpoints for new products and processes.
- Participate in investigations and risk assessments related to manufacturing deviations and changes and ensuring appropriate actions are implemented.
Professional Experience & Qualifications
- Required Degree or Certification: BS desirable.
- 2 years + relevant experience in Pharmaceutical, Manufacturing, GMP Environment.
- Knowledge of current Good Manufacturing Practices (GMPs).
- Excellent Communication & Interpersonal skills
- Exemplary attendance and time-keeping record
- Excellent Computer Skills
Type:
Contract – 12 Months. Normalised office hours. Site Based.
Package:
Circa €80 - €100 Per Hour - Generous and competitive compensation is available to the successful candidate.
For a confidential discussion on this or any other current opportunities please contact Mark Farrell mark@logiskills.ie
mark@logiskills.ie
IAC-Mar22