A Senior QC analyst is required to join a global pharma company based in North Dublin. This role is the perfect move for an experienced analyst looking to gain more people management exposure.
The role reports to the QC manager and the tasks carried out include the following:
- Creating weekly work schedules with the Laboratory Management and ensuring that these schedules are communicated and followed.
- Checking raw materials, in-process and finished product work.
- Trending of raw materials, in-process, finished product results.
- Reviewing analyst documentation and ensuring Right First Time KPIs are achieved.
- Issuing monthly / annual reports to the Laboratory Management
- Ensuring that all Quality Systems within the department are adhered to on a daily basis.
- Trouble-shooting within the QC Department and providing technical assistance / support to other Departments
- Maintaining laboratory SOPs and specifications in a state of compliance.
- Training of QC staff and regular review of training records.
- Co-ordinating, initiating, reviewing and approval of change of controls or any deviations and Laboratory Investigations relating to the QC area.
Applications must possess the following knowledge, skills, qualifications and experience.
- At least 3-4 years' experience working within a cGLP environment (HPRA and FDA approved).
- People management experience of 1-2 yrs. within a lab environment with a proven track record of effectively scheduling & delegating Analysts' work would be desirable.
- A BSc in a related discipline is a must.
- Extensive experience with HPLC, IC & GC
- Ability to critically review analytical data.
- Ability to advise, lead and manage a small team of analysts.
- Ability to trouble shoot, identify analytical issues and follow up with corrective actions.
- Experience of preparing for regulatory audits.
- Prior experience of implementing training modules
- Experience with applications such as E09,Trackwise, LIMS sample manager and Chromeleon
Morgan McKinley is acting as an Employment Agency in relation to this vacancy.
Please note that any references to salary or pay rates in this advertisement and in the salary refinement section are indicative only and should only be used as a guide.