Job description

Job responsibilities

• Day to day and training of Quality Control (QC) Scientists / Technicians.
• Lead and perform QC chemistry testing including In-process testing, Finished product testing, Container/closure tests and QC sample analysis.
• Manage QC chemistry testing - raw materials (RM), consumables/ packaging/ components (CPCs), in process testing, finished products in compliance with the pharmacopoeia and any other samples (e.g. filters, water samples), including appropriate sampling plans.
• Release raw materials and CPC for use in production of aseptic medicines.
• Contribute to the MMC facilitys strategy to cleaning validation including managing residue testing.
• Manage filter integrity testing for production processes.
• Develop stability test plans in agreed with ICHQ1 and perform stability and ongoing stability tests, ensuring appropriate sample management.
• Collaborate with the QC Lab Manager to obtain required documents for supplier approval of raw materials and CPCs.
• Manage QC documentation, including SOPs, worksheets, and QC reports.
• Oversee QC equipment qualification, calibration, repairs and servicing.
• Support QC validation scientists as directed with new analytical methods.
• Ensure appropriate management, validation, and storage of QC reference standards, reference samples, and retention samples.
• Manage lab stocks including reagents and implement an expiry monitoring plan.
• Act as Pharmaceutical Quality System (PQS) lead for QC, including ensuring QC data integrity, leading QC deviations and Out-of-Specification (OOS) investigations, managing change control processes (QC assessment) and implementing Corrective and Preventative Actions (CAPA).
• Maintain accurate QC data recording, trending, and statistical analysis, including use of lab databases (e.g. LIMS), sample management, and labelling.
• To role model compassionate and inclusive leadership in order to shape the creation of a collective leadership culture within the trust. This means demonstrating a consistent leadership style which (a) engages, enables and empowers others (b) uses coaching to promote ownership of learning and quality improvement and (c) facilitates team working and collaboration within teams / departments and across organisational boundaries.

Person Specification

Qualifications / Professional Registration

Essential

• Degree in relevant scientific discipline e.g. chemistry, pharmacy.

Desirable

• Professional Registration.
• Post graduate qualification in Analytical Chemistry / Pharmaceutical Analysis.
• Post graduate qualification in Quality Assurance / GMP.
• Management Qualification.

Experience and knowledge

Essential

• Post qualification experience in the analytical techniques used in pharmaceutical quality control as per British Pharmacopoeia requirements.
• Knowledge and experience in implementing laboratory safety requirements. e.g. COSHH.

Desirable

• Experience of using Quality Management Systems, including, leading out-of-specification investigation, root cause analysis tools, change controls, document management.
• Experience in QC testing requirements of sterile medicines as per Annex 1.
• Experience in line management.
• Knowledge of or experience in coaching and mentoring practices and tools.

Disclosure and Barring Service Check

This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.

Certificate of Sponsorship

Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).

From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).

Employer details

Employer name

Northumbria Healthcare NHS Foundation Trust

Address

Northumbria Healthcare Manufacturing and Innovation Hub

Avenue Road

Seaton Delaval

NE25 0QJ

United Kingdom

Employer's website

https://www.northumbria.nhs.uk/ (Opens in a new tab)