Description
Global Health Care Company is seeking a QA Manager and QP to join there management team in their brand new site. It is a permanent full time role with an attractive salary and benefits package.Day to Day:
- Managing Dry Powder Inhalation (DPI) manufacturing site operational Quality systems by leading the construction and maintenance of the Quality Management System supporting operational and release functions.
- Build a team of QPs to ensure release functions are in line with EU directives for the certification of medicinal products for Inhalation for the company.
- Quality oversight of commissioning and qualification of site and equipment project builds.
- Act as Quality SME for Technical Transfer activities.
- Ensure compliance functions in the operations team are managed adequately.
- The successful candidate will act as the subject matter expert with respect to the HPRA (IMB) and FDA along with providing QP leadership, support and guidance to business lines with a focus on drug product manufacturing, assembly, testing, release operations, commissioning, qualification and process development.
Requirements:
- Educated to degree level and/or 5 years plus experience in pharmaceutical QA/QP roles.
- Demonstrated previous QP positions for at least 5 years.
- Have had previous experience of external influence in the pharmaceutical industry including front line regulatory interaction.
- Capable of forming strong professional relationships across all functional lines and gain the respect of those in partner lines.
- Experience in Inhalation processes will be an advantage
- Strong leader and able to work well under pressure.
- Willing to expand knowledge base and learn and then implement the new learning
- Efficient and well organised in work execution practices.
If you are interested in this great opportunity and have the appropriate skill set and experience please contact me Anna Mooney or apply below with an up to date CV.