Senior QC Analyst – Stability
Onsite initially and then Hybrid
Put your career on track with this QC Stability co-ordinator position, if you have worked as a documentation reviewer QC or have strong stability analytical knowledge and are ready to take a step into this role, please read on and apply.
The primary purpose of the role is to plan and execute all activities associated with the stability programmes of the site and associated third parties, to include that of commercial products, investigative medicinal products for clinical trials and experimental products. The role also has responsibility for the development of stability reviewers.
The ideal candidate for this role will be a person who has a minimum of 3 years in a similar role and ideally has previous analytical experience. Strong knowledge of the regulations governing stability programmes also required. Experience of working with and maintaining stability chambers and associated equipment is a must.
The following is a non-exhaustive list of the type of tasks and responsibilities associated with the role:
- Manage stability programmes according to ICH for routine commercial products, Investigational Medicinal Products and non-routine requests.
- Co-ordinate transfer of stability samples from approved third party manufacturing sites.
- Ensure the effective day-to day running of the stability programmes. Organise the planning and scheduling of samples to be put on or pulled from stability. Ensure all stability schedules are adhered to and to co-ordinate sample testing with the QC laboratories both external and internal.
- Review analytical stability documentation that has been generated within department for both commercial and none commercial products.
- Critically review stability data and liaise with Technical Affairs, clients and corporate QA on any out of trend data.
- Amendment, review and approval of stability test methods and procedures.
- Perform laboratory investigations to resolve non-conforming data or out of trend data and liaising with clients on any non-conformances.
- Review, generate and implement all stability protocols.
- Compile formal stability reports including Time-Point and End of Study reports.
- Ensuring that all stability equipment is calibrated and is maintained properly. That all annual validation, calibrations and PM are carried out as required. To review all equipment documentation and ensure they are in accordance to current guide lines.
- In the case of new stability equipment, maintaining and reviewing all equipment documentation (i.e) IQ, OQ and PQ’s, Contracts, calibration / validation documentation and calibration certificates,
- Development of a team of stability reviewers.
The successful applicant must possess the following knowledge, skills, qualifications, attributes and experiences.
- At least 3 years' experience working within a cGMP environment (HPRA and FDA approved).
- A BSc in a related discipline is a must.
- Extensive analytical experience is required.
- Ability to critically review analytical data. Possessing excellent attention to detail is a must.
- Ability to advise a small team of analysts.
- Ability to troubleshoot, identify analytical issues and follow up with corrective actions.
- The ability to work well with all key contacts both internal and external to the organisation.
Reach out in confidence to email@example.com