Head of QA - Edinburgh, United Kingdom - Hobson Prior

Hobson Prior
Hobson Prior
Verified Company
Edinburgh, United Kingdom

2 weeks ago

Tom O´Connor

Posted by:

Tom O´Connor

beBee Recruiter
Description

Salary:

£ £80000 per annum
Job type:

Permanent


Location:

Edinburgh, Scotland


Function:

Quality Assurance, Quality Engineer


Posted:07/08/2023


Ref:

BBBH2330- Hi I'm
Ben
, I manage this role


Hobson Prior are looking for a Head of QA to join a pharmaceutical corporation on a permanent basis located in Edinburgh.

Our Client is focused on evolving and commercialising inoculations for infectious illnesses.

Please note that to be considered for this role you must have the right to work in this location.


Key Responsibilities:


  • For this role, you will establish, lead, manage and develop quality assurance staff, as well as policies, procedures, and processes to ensure effective, efficient, and accountable use of these resources.
  • Ensure compliance with all facilities, systems, processes, and best work principles during manufacturing, testing, and release of products.
  • Assist other senior quality assurance personnel on site with the development, monitoring, improvement, and maintenance of procedures to ensure compliance with EU / FDA Good Manufacturing Practice and Good Distribution Practice.
  • Provide guidance and oversight to ensure deviations, changes, and CAPAs in the area of responsibility are escalated and addressed accordingly.
  • Maintain the site audit systems and processes to support compliant business operations through selfinspection and external audits.
  • Provide management with key audit quality metrics to drive compliance and continuous improvement within organizations compliance programs.
  • Lead audit / regulatory inspection preparation, hosting, and making sure response is timely.
  • Ensuring compliance with key investigations through QA leadership.
  • Follow Standard Operating Procedures to manage and review documentation (Including CAPA, Change Requests, Deviations (including Quality Investigations and OOS), Product Technical Complaints, QMS data logs,Room Release documentation, Batch record review (including PPRs, PTRs, MPRs and SPRs), Fill / finish documentation).
  • Ensure batch release duties are met, including issuing Certificates of Conformance for bulk drugs.
  • Monitor and manage performance metrics on time.
  • Report quality issues to the Quality Review Board (QRB) and global quality governance bodies according to quality requirements.
  • Report any material breach of quality or regulatory compliance to the Site Director, Director of Quality Operations, and your qualified person(s).
  • Participate in delivering the Quality strategy to support the site processes and operations by delivering businesseffective compliant systems.
  • Work with the site QP to deliver system and batch documents that satisfy batch release requirements.
  • Provide deputisation when necessary and perform any other reasonably requested duties by the Director of Quality Operations.

Key Skills:


  • Ability to manage a large amount of work in a timely manner.
  • Ability to communicate clearly and effectively in a variety of situations.
  • Active selfstarter with a proven ability to inspire and motivate a team of productive professionals.
  • Proven ability to manage one's own workload and the workload of others in the team.
  • Ability to multitask and work under changing priorities in a fastpaced environment.

Requirements:


  • An educational background of at least a bachelor's degree or an equivalent experience is required.
  • Regulatory knowledge and operational management experience, operating to GMP/GPD standards and regulatory requirements.
  • Knowledge of EU / FDA and cGMP / GDP requirements for biological product manufacturing and testing.
  • The ability to plan, coordinate, and implement quality improvement programs in a variety of settings.
  • The ability to understand and work in the pharmaceutical industry.
  • Strong work ethic, experience with tight deadlines, and ability to reorganize workload.
  • Experience using operational excellence tools to improve performance.
  • An understanding of the quality metrics and experience of leading and delivering them.
  • It may be necessary to work overnight or out of hours depending on the circumstances.


Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe.

Hobson Prior is acting as an Employment Agency in relation to this vacancy.
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