Bath ASU is the largest privately-owned pharmaceutical company in the UK and with our sister companies Pharmaxo, Microgenetics and Corsham Science Ltd we employ over 400 team members; the best part is that number is ever-growing. We are an aseptic specials 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.
As the QA Manager, you will manage quality systems, processes, and procedures to assure product safety, whilst driving continuous improvement. The QA Manager owns and maintains the pharmaceutical quality system and communicates this status to the Head of Quality and Head of Production.
Duties and responsibilities
- To provide senior leadership and management to the Quality Assurance team, act as a role model, develop and provide strategic direction and be responsible for the, Quality Assurance and Quality Control departments, to support the operational delivery of 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:
- Compliance of Quality Systems, procedures and practices through systematic application of the internal audit process.
- 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.
- Taking the lead 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 review and optimization of the company's pharmaceutical quality system by preparing review.
- To establish a 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 cross-functional/organizational relationships to influence site compliance to Quality policy, Pharmaceutical Quality System procedures and guidelines.
- To manage day-to-day activities of the QA Team.
- To write, review, and/ or approve internal SOP’s and other GMP related documentation.
- Pro-actively 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
- To undertake continuing professional development and attend any suitable training and update courses as deemed necessary and ensure a high level of competency is achieved.
- 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 Head of Quality.
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:
- Extremely competitive Salary (dependent on experience, knowledge and skill set)
- Bonus and Incentive Plan
- Life Insurance
- Generous Company pension scheme
- Company car (electric/hybrid) or car allowance
- Private medical insurance
By clicking ‘apply’ you will be taken to our careers page to complete your application.