Quality Technical Manager – Sterile Injectables

at  Langton Howarth

Wrexham/Permanent Full Time
Hybrid Office 3 days P/W WFH 2
Our client is a market leader in the sales and distribution of generic injectables. These are sold into NHS hospitals and private clinics via a pharmaceutical wholesaler in the UK. My client prides themselves on customer service and ensuring that every client gets the stock they need to care for their patients. They hold an unrivalled amount of stock of injectables to ensure quick and safe delivery.
They truly care not only about the patients and their healthcare clients, but they also care about their employees. They offer unrivalled benefits – 28 days holiday PLUS bank holidays, private healthcare, up to 10% matched pension contribution, 4x Death in Service, Critical Illness, hybrid working and a bonus of up to 25% of base salary based upon company performance to name just a few of the ways they look after their team.
The offices are nestled in the grounds of a beautiful stately home and their team is expert, long-standing and are truly passionate about delivering quality sterile generic injectables.

Due to the upcoming retirement of a long-standing and expert employee, they are now seeking an experienced Quality & Technical Manager to be the Responsible Person (RPi) on a wholesale Dealer Authorisation. Reporting to the Managing Director, as The Quality and Technical Manager you will: -Act as the Quality Management System Administrator and perform all associated duties.

• Manage and undertake the administration of quality complaints.
• Preparing management documentation
• Preparation and update of SOPs
• Manage Medical Information Service provider & respond to MI enquiries where required.
• Preparation, management and review of technical agreements and safety data exchange (PV) agreements
• Liaise with Marketing Authorisation holders concerning pharmacovigilance responsibilities.
• Reporting of Medical Information and PV data to MA holders
• RPi duties for the Company & deputy Consultant RPi as required.
• Supplier routine audits & audits for cause with consultant QP/RPi
• Annual Staff Training for PV & GDP

• Manage and undertake the administration of quality complaints.
• Preparing management documentation
• Preparation and update of SOPs
• Manage Medical Information Service provider & respond to MI enquiries where required.
• Preparation, management and review of technical agreements and safety data exchange (PV) agreements
• Liaise with Marketing Authorisation holders concerning pharmacovigilance responsibilities.
• Reporting of Medical Information and PV data to MA holders
• RPi duties for the Company & deputy Consultant RPi as required.
• Supplier routine audits & audits for cause with consultant QP/RPi
• Annual Staff Training for PV & GD