QA Specialist
| Reference: | BCHQ00000326 |
Location: |
Cork
|
| Qualification: | Degree | Experience: | 2-3 Years |
| Job Type: | Fixed Term Contract | Salary: |
Not Disclosed |
QA Specialist
Reporting to the QA Manager, this is a 12 month contract role with our Pharma client in Cork
Responsibilities
- Required to work, in an FDA / IMB approved GMP manufacturing facility, in ensuring compliance to new and established systems and global regulations and guidelines for a wide range of pharma products
- Must work as part of a team with an emphasis on continual improvement of processes, quality management systems and compliance. The position requires good communication skills, organization and an eye for detail.
- Issuance, Control and Review of Production Batch Records
- Preparation of SOP's and carrying out document review/updating as appropriate
- Manage the Deviation/CAPA and Change Control Management Systems
- Participate in cross functional teams for the introduction of new products/processes, carrying out risk assessment and preparation/approval of cleaning documentation associated with these activities
- Carryout GMP training for site employees and play an active role in site quality initiatives
- Ensure all site calibrations and utilities are carried out and maintained in a compliant manner
- Participate in all aspects of audits by Regulatory Authorities and Customers
- Conduct internal audits as per agreed schedules.
- Be proficient in the use of IT based systems for document control, material resource planning (SAP), etc.
- Demonstrate a flexible approach and participation in company wide improvements plans.
- To become familiar with all aspects of the Quality Department and deputize in the absence of other Quality Assurance Specialists when requested.
- Other duties as required by the department manager, which is in keeping with the nature of the role.
- To take reasonable care for your health and safety and for others in the workplace
Requirements
- B.Sc. Degree in a technical or scientific based subject - Chemistry, Biochemistry, etc.
- Minimum of 2-3 years in a QA Specialist or Compliance Role in a Regulated Pharmaceutical Industry (API and/or DP manuafcture)
- Competent and knowledgeable of all relevant ICH guidelines
- Excellent communications skills
- Flexibility is essential
- Proven ability to work on own initiative
- PC skills MS Word, Excel, PowerPoint, MS Project, etc.
If you would like further information you can contact:
Brian Christensen | Tel: +353 (0) 1 685 4747