Fastnet The Talent Group
Responsibilities. Supporting the full range of daily compliance activities on the Cark site and sister site in Denmark This will involve travel to the Danish manufacturing site. Day to day compliance activities include: raw material and intermediate release, Change Control, Deviations, supporting QC Laboratories, Maintenance and Operations departments. Taking the lead role in preparation for and handling of internal audits and regulatory inspections, Collaboration with other functions both globally and locally on Quality Improvement Initiatives. Contributing and participating in Quality and Process improvement initiatives within API manufacture. Participating in timely execution of KPI for the Quality department. Participating in continuing professional development in order to maintain awareness in current and new regulations and ensuring new regulations are implemented. Requirements. Minimum qualification of a Batchelor level degree in Chemistry, Microbiology or a related discipline. Broad Quality compliance exposure with at least 6 years' experience within the pharmaceutical industry. Experience working across a Global business would be a distinct advantage. Skilled in the execution of Risk Assessment and variety of problem solving techniques. LEAN and Six Sigma experience. Ability to work with stakeholders and have a hands-on operational approach to Quality. Excellent communication skills and collaborative approach to the workplace. Contribute with a positive and constructive attitude. Ability to work on your own initiative. Ability to critically assess issues and devise and execute appropriate solutions using problem solving techniques in a decisive manner. Strong business mindset acumen. 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.
194 days ago