Quality Officer – INTERNAL

King's College London

Job id: 079445. Wage: £36,532 – £37,182 every year, together with London Weighting Allowance.

Posted: 20 November 2023. Cut-off date: 26 November 2023.

Enterprise unit: College of Life Sciences & Drugs. Division: Complete Most cancers Centre.

Contact particulars:Sharon Lehec. [email protected]

Location: Denmark Hill Campus. Class: Skilled & Help Companies.

Job description

The Cell and Gene Remedy, King’s (CGT-Ok) group manufactures quite a lot of Superior Remedy Medicinal Merchandise (ATMPs) and beginning supplies, in state-of-the-art Good Manufacturing Observe (GMP) amenities for therapy of most cancers and uncommon ailments. This put up helps the interpretation of cutting-edge medical analysis into medical software. The place relies in a workforce with a superb monitor report in each primary and translational analysis.

The High quality Officer will work as a part of the High quality Assurance Crew to offer high quality assist to CGT-Ok manufacturing actions and make sure the activties adjust to the necessities of the Pharmaceutical High quality System (PQS).

Activity undertaken will embody however not be restricted to;

  • doc management
  • helping in offering coaching on the PQS and overseeing compliance of the workforce with the coaching program/ coaching necessities
  • evaluation of batch documentation
  • provider qualification
  • collaborating in inner and exterior audits
  • helping within the implementation of PQS enhancements together with corrective and preventative actions.

The High quality Officer will play a key function in guaranteeing the activties of the Cell and Gene Remedy group keep compliance with UK and EU Good Manufacturing Observe rules.

The High quality Officer might be accountable to the Head of High quality and work with members of the workforce from all areas together with Manufacturing, High quality Management and Technical.

This put up might be provided on a hard and fast time period contract for one yr.

It is a full-time put up – 100% full time equal.

Key obligations

  • Oversee doc management activties for the CGT-Ok group throughout all licenced websites, together with annual / bi-annual evaluation of paperwork, issuing doc IDs, evaluation and activation /approval of documentation, issuing batch report paperwork and upkeep of the doc management database.  
  • Oversee the monitoring and monitoring of the coaching of the Cell and Gene Remedy group personnel.
  • Help the Head of High quality in offering coaching on the PQS and creating a coaching guide.
  • Perform the qualification of suppliers as per the PQS necessities.
  • Perform the issuing / approval of labels utilized in manufacturing and QC testing.
  • Perform preliminary critiques of batch documentation
  • Take part within the conduct of inner and exterior audits.
  • Take part within the administration of change management for each high quality and manufacturing actions
  • Help the QA and Manufacturing Crew within the monitoring and closeout of deviations, non-conformances and high quality exceptions as required.
  • Draft high quality system documentation together with however not restricted to Customary Working Procedures and Batch Manufacturing Information.
  • Help the Cleanroom Technicians within the evaluation and approval of essential reagents and supplies
  • Help the Head of High quality with the collation of metrics referring to the efficiency of the PQS.
  • Take part within the authorisation of CGT-Ok manufacturing amenities to be used, together with evaluation and approval of weekly facility and gear logs and out-of-specification (OOS) occasions. Elevating High quality Expectation Information (QER) within the occasion of an OOS occasions and following the QER via to closure.

The above checklist of obligations will not be exhaustive, and the put up holder might be required to undertake such duties and obligations as could fairly be anticipated throughout the scope and grading of the put up.  

Abilities, data, and expertise

Important standards  

  • Diploma or larger in one of many Organic Sciences  
  • GMP and GCP coaching 
  • Working data of all elements of High quality Assurance in relation to manufacturing of superior medicinal merchandise particularly change management, doc Management, coaching, deviations and CAPA, high quality threat administration 
  • Expertise in implementing and sustaining High quality Administration Methods particularly doc management, deviations and CAPA, coaching, batch launch and validation. 
  • Expertise of working inside a MHRA licenced GMP manufacturing facility and of ICH Q10 compliant High quality Methods. 
  • Expertise in writing high quality system commonplace working procedures 
  • Expertise with digital high quality administration programs e.g., QPULSE and particularly doc management via an digital QMS. 
  • Potential to construct efficient working relationships 
  • Glorious consideration to element. 
  • Glorious organisational expertise with a demonstrable capability to stability competing calls for and priorities. 
  • Fascinating standards

  • The power to be proactive and organise personal duties  
  • Expertise in utilizing instruments for course of enchancment, for instance, 6- sigma 
  • Expertise of chairing conferences and taking formal minutes 
  • Additional data

    This put up is topic to Occupational Well being clearance.

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