QA Specialists

Fastnet The Talent Group

Cork

Responsibilities. Work in an FDA / HPRA approved manufacturing facility. Ensure compliance to new and established systems, global regulations and guidelines for a wide range of DPIs, APIs and intermediates. Promote a mature quality culture. Issuance, control and review of production batch records. Review/release of all APIs; Pre-QP batch record review for DPIs. Lead and participate in validation activities including issuance of process validation protocols, reports and VMPs. Participate in cross functional teams for the introduction of new products/processes. Preparation/approval of cleaning documentation. Participate in cross functional investigations, advise on corrective actions and assist with their implementation. Carryout GMP training. Participate in all aspects of audits by Regulatory Authorities and Customers. Conduct internal audits as per agreed schedules. Deputise in the absence of other Quality Assurance Specialists when requested. To take reasonable care for your health and safety and for others in the workplace. Requirements. BSc. Degree in a technical or scientific based subject. 1 years in a QA Specialist, Validation or Compliance Role in a Regulated Industry (API/ Drug Product/ Biopharma, Medical device, etc. Work as part of a team with an emphasis on continual improvement. Flexible with excellent communication skills, ability to work on own initiative. Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent. Fastnet - The Talent Group. 'Not Just Placers.........Partners' The Life Science Specialists. This job originally appeared on RecruitIreland.com.

2493 days ago