Our client based in the Munster region now have a vacancy for a QA Specialist. This is a 12 month contract commencing ASAP.

The Role:

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 complex active pharmaceutical ingredients and intermediates

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 for API batches and intermediates.

Review/Release of all API and Intermediates as appropriate

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 investigations involving RCA's (root cause analysis investigations), advise on corrective actions and assist with their implementation.

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

Personal 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 manufacturing)
Competent and knowledgeable of all relevant ICH guidelines, particularly ICH Q7A, EU GMP guide annex 18, and all FDA requirements relating to 21 CFR 210 and 21 CRF 211
Excellent communications skills
Flexibility is essential
Proven ability to work on own initiative
PC skills MS Word, Excel, PowerPoint, MS Project, etc.

For further information please call Ciara at 01 2784671 or email your CV in the strictest confidence to cbyrne@thornshaw.com. Log on to www.thornshaw.com for more jobs.