Deputy QA Manager - Corsham, United Kingdom - Bath ASU

Bath ASU
Bath ASU
Verified Company
Corsham, United Kingdom

3 weeks ago

Tom O´Connor

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Tom O´Connor

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Description

Deputy QA Manager

About us


Bath ASU is the largest privately-owned pharmaceutical company in the UK and with our sister companies Pharmaxo Healthcare, Microgenetics and Corsham Science Ltd we employ over 400 team members; the best part is that number is ever-growing.

We are an asepticspecials manufacturer based in Corsham, Wiltshire.

Formed in 2006 from Bath University, we are a growing company and supply life-changing medicines to over 275 hospitals UK-wide.


About you


As the Deputy QA Manager, you will assist the management of quality systems, processes, and procedures to assure product safety, whilst driving continuous improvement.


The Deputy QA Manager leads and maintains the pharmaceutical quality system and communicates this status to the QA Manager, Head of Quality and Head of Production.


Duties and responsibilities

  • To provide leadership and management to the Quality Assurance team, support the development of the quality strategy and support the QA Manager in being responsible for the Quality Assurance and Quality Control departments. Support the operational deliveryof pharmaceutical manufacture and wider business support functions.
  • To monitor, drive and report conformity with the legal responsibility to ensure all products are compliant with current Good Manufacturing Practice (cGMP) and the requirements of the licenses (Specials, Investigational Medicinal Products and Home Office)including:
  • Ensuring that all equipment, computer systems, processes, cleaning, temperature controlled units/ areas are validated in accordance with applicable regulations and guidelines
  • Ensuring the Pharmaceutical Quality System meets requirements
  • Supporting the QA Manager during MHRA, customer and visitor audits/inspections on all aspects of Quality Assurance functions
  • To provide effective management reviews and documentation of relevant quality Key Performance Indicators, illustrating quality system processes and audits to ensure excellence and efficiency of the Pharmaceutical Quality System
  • To support the quality risk management approach in projects based on six sigma concepts and training to ensure that quality is understood and managed by all stakeholders throughout the product life cycle
  • To engage strong intradepartmental and crossfunctional/ organisational relationships to influence site compliance to Quality policy, Pharmaceutical Quality System procedures and guidelines
  • To support the QA Manager in managing the daytoday activities of the QA Team
  • To write, review, and/ or approve internal SOP's and other GMP related documentation
  • Proactively participate to the optimization of the quality system by proposing new procedures, tools, or modification of existing ones
  • To define and perform audit of internal systems and external suppliers and manufacturers
  • Participate in the oncall rota

Secondary duties (or those that may be required to support the Quality Assurance Team):

  • To be responsible for the Approval for Use (release) of all products manufactured or repackaged within Qualasept according to licensing requirements, GMP and professional discretion.
  • To provide advice and information on all aspects of pharmaceutical quality assurance and production.
  • To support the training and development of Production and Quality staff.
  • To ensure that staff comply with COSHH and Health and Safety Regulations and appropriate departmental procedures.
  • To support the development of activities and policies aimed at improving the effectiveness and efficiency of the service and improvement of the pharmaceutical quality system.
  • Other duties as required by the QA Manager.
This job description is not intended to be exhaustive. The post holder will be required to be flexible and take on projects and responsibilities as the company grows.


In return we offer rewards and benefits including:

  • Competitive salary (dependent on experience, knowledge and skill set)
  • Bonus and Incentive Plan
  • Life Insurance
  • Generous Company pension scheme
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