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Details

QA Specialist


Reference:BCHQ00000326 Location: Cork
Qualification:DegreeExperience:2-3 Years
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: QA

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