Quality & Technical Manager - Langton Howarth Ltd : Job Details

Location: 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 injectable medicines to the NHS & Private hospitals.

With a 'patients first’ approach, our client prides themselves on offering a very high standard of customer service alongside a market leading supply record, providing security & value to the NHS & private clients

The existing team at the company is longstanding, all being handpicked for their expertise and talent; each has a personal commitment to excellence and the core values of the company. Our clients’ staff enjoy an outstanding and comprehensive package of benefits and luxury offices in beautiful North Wales.

28 days holiday PLUS bank holidays, private healthcare, contributory pension, death in service & critical illness cover, discretionary performance related bonus based on company performance,

The upcoming retirement of a long standing and expert employee, means that our client is now seeking an experienced Quality & Technical Manager tojoin the management team as the Responsible Person (RPi) on a wholesale Dealer Authorisation.

Reporting to the Managing Director, as the Quality & Technical Manager you will:

• Act as the Quality Management System Administrator and perform all associated duties
• Manage and undertake the administration of quality complaints.
• Preparemanagement documentation
• Prepare and update 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 with respect to pharmacovigilance responsibilities.
• Report Medical Information and PV data to MA holders
• UndertakeRPi duties for the Company & deputy Consultant RPi as required
• Routine Supplier audits with consultant QP/RPi
• Conduct annual Staff Training for PV & GDP

The ideal Technical & Quality Manager will already have: -

• Minimum of 5 years’ experience in a pharmaceutical environment, preferably sterile injectables, managing QMS compliance in a cGMP/GDP environment
• Must have sterile injectables/Quality Management Systems/Quality Assurance/Medical Information/Pharmacovigilance experience, either from manufacturing generic injectables or pharmaceutical distribution, sterile injectables sales and distribution companies
• Must have a science degree or equivalent
• Must have the qualifications/experience to be an RPi on a wholesale dealer authorisation.
• Ability to travel infrequently (once or twice a year to European suppliers’ sites) and to suppliers’ sites in the UK - less than 10%

The role is hybrid, 3 days per week from Wrexham and the other two days working from home.

You will need your own car and full clean driving licence to travel to and from the office. Free parking is available on site.

You must have full right to work in the UK without requiring any form of visa sponsorship and hold a valid passport.