Quality Manager - Pharma

Job description

We are looking for a Quality Manager (Pharma) at Sheffield.

Your Role

Responsible for the management of the day to day quality function at Chapeltown working with the operations team, site management and the UK Head of Quality to ensure the following: The maintenance and future development of the Quality Management system, To ensure compliance to EU directives, Regulations and EU/MHRA guidelines on Good Distribution Practice and KN Policy, Ensure rapid release of received product in out of stock situations, Driving resolution of non-compliances when such issues occur and driving a continual quality improvement programme across the site. To act as the Site Manager when the Site Manager in their absence. To manage and provide practical support to the dedicated Kuehne + Nagel Ltd site on all aspects of Quality, Safety, Health and Environment.

Your Responsibilities

·  To conduct routine checks / sign off of the temperature monitoring system employed at the site. Manage the temperature mapping programme. Manage calibration and validation of critical equipment
·  To conduct, document and sign off routine self- inspections of the facility / processes. Ensure Cleaning activities are performed at the site according to the schedule – routine sign off
Manage all recalls at the site (including mock recall. Returns management – review to approve to saleable stock or send for destruction
·  Waste destruction – Management of waste through nominated waste destruction company including certificate management. Ensure SOPs / Work Instructions are in place, maintained, reviewed and improved
·  Management of the site training program. To liaise with the pest control service provider to ensure that all inspection visits are completed according to the agreed schedule and the results of all inspections are fully documented
To support the RP during customer or authority audits and scheduled self-inspection audits. To respond to any temperature deviations caused by any mechanical breakdown / malfunction of the temperature management systems
·  Report any suspected counterfeit or falsified products to the RP or during times when the RP is absent, report the details to the MHRA. Review TIPs (Non-conformances / deviations / complaints) and ensure timely investigation and closure
Continuous Improvement of the Quality Management System. Manage the Quality / QSHE team in their activities to ensure:
·   The timely release of medicinal products distributed from site to the UK market to minimise out of stock periods.
·  Quality related activities are completed efficiently, effectively and records are maintained and readily available

Your Skills and Experiences

·  Working knowledge of Quality Management Systems ISO 9001, ISO14001 and OHSAS18001.
·  Qualified internal auditor to either ISO9001, 14001 or OHSAS18001 desirable.
·  Successfully completed the MHRA accredited Responsible Person course.
·  Experience in a Quality Management role, preferably in pharmaceutical warehousing and distribution
Minimum 2 years’ experience in similar Health & Safety role
·  Excellent knowledge of Goods Distribution Practices / Pharma & Healthcare supply chain and storage requirements
Good understanding of Operational Warehouse environment & Transport operations
·  Knowledge of COMAH (Control of Major Accident Hazards), LNG and Hydrogen and HACCP (Hazard Analysis and Critical Control Point) desirable.
·  Ability to prioritise and work from own initiative. Excellent PC skills (ability to use all MS Office products to a high standard. Previous knowledge and/or experience of warehousing logistics and other transport businesses

Good Reasons to Join

If you would like to become a valued member of our team then we will also make sure that you’re rewarded for your commitment and expertise. You will also have the opportunity to join the contributory Kuehne + Nagel pension plan and benefit from our Route 2 Rewards scheme which offers discounts and savings on a wide range of high street or internet goods and services.","industry":"Logistics