Job description Posted 13 July 2022

QA Specialist

Location: Brentford

Pay: £63.86 per hour via (Umbrella inside IR35)

Contract: 12 Month Contract


Working under the oversight of the Quality & Validation Manager: 


With experience in a pharmaceutical manufacturing organisation in a Quality focused role, the successful candidate will work alongside the Business and Tech teams to deliver oversee delivery and steer the remediation programme based on the learnings from RCA Investigation and Audit Findings, ensuring Company and Regulatory commitments for GxP applications and data are met. 


Responsibilities (Job Role) 

Oversight and management of Quality processes (fulfilling the Quality Assurance role) in accordance with the relevant processes (e.g. Quality Management System) 

·      Review and quality approval of incidents, issues and investigations and to determine if further corrective actions need to be embedded into remediation plan.

·      Support training activities for items such as GMP or other Quality related mandated training as well as providing mentoring and coaching colleagues in all relevant aspects of GMP.

·      Ensuring robust communication and escalation of Quality and Compliance issues to the Quality Management. Ensuring issues/risks are identified, mitigated and/or escalated

·      Review and approve documents as the Quality representative such as SOPs and technical reports. Support document review and understand the impacts of change control in the area

·      Understand use of QMS and its application.

·      Understanding of the regulatory requirements for the area(s) being supported.

·      Generation of quality agreements for third parties

·      Assessment of third party risk models


Skills & Experience

·        Understanding of pharmaceutical manufacturing and distribution regulations, guidelines, principles and expectations 

·        Demonstrated ability to interpret and apply company guidelines, principles and expectations

·        The ability to work in and lead cross functional teams.

·        Flexible working as determined by the Business needs.

·        Good organisation and attention to detail, ability to function in an atmosphere of constant change with detailed accuracy.

·        Effective communicator with ability to collaborate and form strong partnerships within teams and diverse stakeholders/customers that result in "win-win" outcomes to achieve business goals and objectives

·        Understanding and ability to demonstrate use of continuous improvement techniques.

·        Knowledge of deviation management and regulatory requirements.

·        Experience in coaching/mentoring various personnel in quality principles and activities

·        Understanding of master data maintenance processes (preferred)

·        Understanding of training processes (preferred)