QC Systems Senior Technical Officer
Location: Wrexham
Duration: Perm
Shift timing: 8.15am until 4.15pm Monday to Friday (Flexi scheme is also offered)
Mandatory requirements – Experienced in pharmaceutical QC Validation, especially HPLC instrument validation, HPLC System validation important too. CSV implementation, supervisory experience, hands on HPLC experience and CDS software skills. HPLC carryover failure knowledge and experience of solving
SCOPE OF THE ROLE
A fantastic opportunity for an enthusiastic QC System Technical Officer to join our team based at one of the largest generic pharmaceutical companies in the UK. The successful candidate will be a quality-driven individual with a keen eye for detail and a strong focus on Good Manufacturing Practice (GMP).
A day in the life of a QC Systems Senior Technical Officer
- You will be responsible for leading a team that schedules and executes planned calibration/maintenance activities, provides technical expertise for all QC equipment ensuring that equipment is procured, implemented, validated and maintained in accordance with site processes and schedules.
- You will be responsible for equipment troubleshooting and proactively liaising with suppliers and QC to ensure rapid resolution.
- You will be responsible for management of activities relating to GMP-relevant QC Computer Systems such as Empower.
- You will ensure QC Systems and data comply with Data Integrity regulations and lead equipment related deviation investigation and reporting.
- You will support quality and efficiency improvement initiatives for QC as well as generating GMP documentation in relation to QC operations and QC automated systems.
What we’re looking for:
- A Graduate (or equivalent) in a relevant scientific discipline
- Previous experience within a pharmaceutical or equivalent laboratory environment is essential.
- A thorough understanding of current GMP, Health and Safety and COSHH regulations.
- Ability to lead a team that schedules and executes planned calibration/maintenance activities on QC equipment
- Strong technical knowledge of laboratory equipment and experience in instrument/equipment qualification, automated systems validation, change management and troubleshooting
- Strong computer skills and knowledge of QC pharmaceutical automated systems such as Empower and LabX, including proficient knowledge and use of Microsoft Office applications.
- Previous supervisory experience in leading a team is preferred.
- Previous experience in representing the QC group at internal, customer and regulatory audits is desirable
- Experience in project planning and delivery would be advantageous.